Advance Your Life Sciences Career

Contract Type: 12-Month Fixed-Term Contract

Location: Ireland (Hybrid/Onsite depending on business needs)

Working Hours: 40 hours per week

Start Date: Immediate requirement

Role Overview:

This organization is executing a multi-year Clinical Supply Chain Data & Analytics Strategy Roadmap designed to transform how clinical trial and supply chain data is collected, governed, and analyzed. The program focuses on building scalable data platforms, improving data quality and compliance, and enabling advanced analytics to support operational and strategic decision-making across clinical operations.

The Clinical Data Engineer will be a key contributor to this initiative, supporting the design and implementation of robust data pipelines and analytics-ready datasets. This role is well suited to an early-career data engineer with a strong technical foundation, exposure to regulated data environments, and a strong interest in clinical trials, life sciences, or healthcare data.

You will work closely with data architects, analysts, and cross-functional stakeholders to convert raw clinical and operational data into trusted, high-quality datasets that enable reporting, dashboards, and advanced analytical use cases.

Key Responsibilities:

Data Engineering & Pipeline Development

• Design, build, and maintain automated data pipelines to ingest, transform, and load clinical trial and supply chain data from multiple systems.
• Implement ETL/ELT processes using modern data transformation tools such as dbt or equivalent frameworks.
• Ensure data pipelines are scalable, reliable, maintainable, and meet performance and availability requirements.
• Support onboarding of new data sources and enhancements to existing data integrations.

Data Modelling & Architecture

• Design and implement data models (e.g., dimensional, analytical schemas) optimized for reporting and analytics.
• Transform raw and semi-structured data into standardized, analytics-ready tables and views.
• Align data structures with enterprise data architecture and long-term analytics strategy.

Data Quality, Governance & Compliance

• Develop and execute data validation, reconciliation, and cleansing processes to ensure high data quality.
• Apply data governance standards to maintain data integrity, traceability, and regulatory compliance (e.g., GxP, GDPR).
• Contribute to documentation, metadata management, and audit-ready data assets.

Analytics & Business Support

• Analyze clinical and operational datasets to identify trends, anomalies, and insights.
• Support the creation of dashboards, reports, and visualizations for operational and leadership stakeholders.
• Collaborate with analytics and data science teams by delivering reliable datasets for downstream use.

Delivery & Independent Ownership

• Manage assigned tasks and workstreams with minimal supervision, ensuring timely and high-quality delivery.
• Proactively identify process improvements, automation opportunities, and data platform enhancements.

Must Have Requirements:

Candidates must demonstrate the following:

• Bachelor’s degree in Data Science, Computer Science, Statistics, or a related field.
• 0–3 years of hands-on experience in data engineering, data analytics, data curation, or a closely related role.
• Strong proficiency in SQL, including writing complex queries and transformations.
• Practical experience with ETL/ELT pipelines, data ingestion, and data transformation processes.
• Working knowledge of Python and/or R for data manipulation and analysis.
• Experience working with structured and semi-structured datasets.
• Understanding of data modeling concepts (e.g., fact/dimension tables, analytical schemas).
• Familiarity with data quality management and validation techniques.
• Awareness of data governance and compliance principles in regulated environments (e.g., GDPR, GxP concepts).
• Experience using data visualization or BI tools such as Tableau or Power BI.
• Strong analytical thinking, attention to detail, and problem-solving skills.
• Ability to work independently, manage multiple priorities, and meet deadlines.
• Strong written and verbal communication skills, with the ability to collaborate across technical and non-technical teams.

Nice to Have Requirements:

The following are desirable but not essential:

• Previous experience within clinical trials, life sciences, healthcare, or pharmaceutical environments.
• Hands-on experience with dbt in a production or project-based setting.
• Certification in Data Analytics, Data Engineering, or a related discipline.
• Certification or experience with specific ETL tools or platforms.
• Familiarity with clinical trial systems (e.g., CTMS, IRT, EDC) and associated data structures.
• Experience working in Agile or Scrum delivery environments; JIRA certification is an advantage.
• Exposure to cloud-based data platforms and modern analytics stacks.
• Basic experience or academic exposure to machine learning or predictive modeling.
• Experience contributing to large-scale, multi-year data transformation programs.

Contract: 12 months with possible extension

Location: Oberdorf, Switzerland (On-site mainly with some flexibility)

Our client, a global leader in the medical device industry, is seeking a motivated Test Technician / Test Specialist to join their product testing and verification team in Switzerland. This role offers an exciting opportunity to work hands-on with cutting-edge medical technologies while collaborating closely with experienced engineers in a highly regulated environment.

Ideal for professionals looking to advance in roles such as Product Test Engineer, Verification & Validation (V&V) Engineer, or Mechanical Test Engineer, this position provides exposure to innovative testing methods, ISO/FDA compliance, and product lifecycle development.

Key Responsibilities

• Plan, coordinate, prepare, and execute recurring mechanical product tests in collaboration with Senior Test Engineers.
• Conduct routine and complex testing activities independently, ensuring accuracy and adherence to SOPs, ISO, and FDA requirements.
• Evaluate and interpret test results, prepare test protocols, reports, and enter data into IT/LIMS systems.
• Support the development and validation of new test methods and contribute to the creation of standard operating procedures (SOPs).
• Maintain and update test instructions and documentation within the document management system.
• Collaborate effectively with internal and external clients to meet testing deliverables and timelines.
• Ensure full regulatory compliance and participate in continuous improvement initiatives to optimize testing efficiency.

Profile & Qualifications

• Completed apprenticeship (e.g., Polymechanic, Laboratory Technician) with 1–2 years of experience in product testing or
• a Bachelor’s/Master’s degree in Biomedical Engineering, Mechanical Engineering, or related field.
• Prior experience in product testing, verification & validation, or medical device testing strongly preferred.
• Knowledge of ISO 13485, ISO 14155, or FDA 21 CFR Part 820 is a strong plus.
• Strong organizational skills, attention to detail, and initiative.
• Excellent written and verbal communication skills (English required; German or French an advantage).
• Proactive team player with a hands-on attitude and the ability to adapt in a dynamic environment.

What’s Offered

• Opportunity to work for a global leader in medical technology, with exposure to high-impact products.
• Full benefits and competitive remuneration package.
• Professional development and hands-on training in product verification, validation, and testing.
• Collaborative and innovative team environment.

Ready to take your regulatory expertise to the next level? Kelly FSP is partnering with a leading global pharmaceutical organization recognized for its strong legacy in innovation, scientific excellence, and commitment to improving patient outcomes worldwide. With operations across multiple therapeutic areas and a robust pipeline spanning pharmaceuticals and medical devices, this organization plays a critical role in advancing healthcare solutions across emerging and established markets.

As a Regulatory Affairs Specialist, you will support regulatory activities across the EMEA region, with a strong focus on collaboration with the Saudi Arabia office. This role is ideal for a regulatory professional who enjoys working cross-functionally, strengthening internal partnerships, and supporting compliance activities without direct health authority interaction or hands-on dossier preparation.

Role Overview

The Regulatory Affairs Specialist will provide regulatory support to assigned products and projects, both new and existing, ensuring alignment with global and regional regulatory requirements. The role involves coordination, documentation oversight, regulatory intelligence support, and internal stakeholder engagement, while acting as a key regulatory contact for local business partners.

This position does not require direct engagement with the Saudi Health Authority and does not involve preparation of regulatory submission documents.

Key Responsibilities

• Ensure compliance with applicable regulatory agency regulations, guidelines, and internal interpretations
• Support responses to regulatory agency questions and internal correspondence, as required
• Organize and maintain regulatory reporting schedules related to new drug applications (NDAs) and investigational new drug applications (INDs)
• Prepare regulatory outputs including outlines, summaries, status reports, memos, presentations, tables, and tracking tools
• Review and approve promotional and non-promotional materials in compliance with corporate and governmental requirements
• Provide regulatory guidance and support to local business partners and internal stakeholders
• Liaise effectively with regional and global Regulatory Affairs teams to ensure alignment
• Conduct searches of existing regulatory records and archives to retrieve requested information
• Maintain, organize, and archive regulatory documentation in accordance with internal standards
• Support regulatory intelligence activities, including tracking competitor regulatory activities and market trends

Functional & Technical Competencies

Must Haves

• Minimum 2 years of Regulatory Affairs experience within the pharmaceutical and/or medical device industry
• Working knowledge of FDA regulations and CE Marking requirements
• Proficiency in MS Office applications (Word, Excel, PowerPoint)
• Strong written and verbal communication skills
• Fluency in English and Arabic (both required)
• Strong organizational and coordination skills
• Ability to work independently and collaboratively in a hybrid environment

Nice to Haves

• Experience supporting EMEA or Middle East regulatory operations
• Exposure to global or matrixed regulatory organizations
• Project coordination or project management experience
• Experience reviewing promotional materials for compliance

Leadership & Behavioral Competencies

• Demonstrates effective collaboration and influence through strong partnerships
• Persists in the face of challenges and adapts to changing priorities
• Listens actively and understands stakeholder motivations, needs, and perspectives
• Manages assigned regulatory activities independently or with limited supervision
• Contributes to competitive intelligence by researching and reporting on regulatory activities of competitors

Education & Experience

• Bachelor’s degree (B.A./B.S.) in a technical or scientific discipline required
• 2–5 years of Regulatory Affairs experience, or a Master’s degree with equivalent experience
• Proven ability to identify gaps in processes and contribute to practical solutions

Additional Role Details

• Hybrid working model: 3 days onsite in Riyadh, 2 days remote
• Full-time, 12-month fixed-term contract
• Start date targeted for March, subject to notice periods
• No direct contact with the Saudi Health Authority
• No regulatory document preparation responsibilities
• Non–Saudi nationality preferred
• The role prioritizes strong communication skills to enhance collaboration within the Saudi Arabia office
• Applications are welcome from all qualified candidates; the current team has a slight preference toward male candidates due to team balance considerations

Diversity & Inclusion

At Kelly OCG, we believe diverse teams drive better outcomes. We are committed to fostering an inclusive environment where individuals from different backgrounds, experiences, and perspectives can thrive and contribute meaningfully.

Contract: 12 months with possible extension

Location: Galway, Ireland (On-site presence required: Full-time, with a flexible hybrid schedule (3 days on-site, 2 days remote)

Kelly FSP, on behalf of leading Medical Devices company, is looking for Senior Design Quality Engineer to provide QA technical and compliance expertise as part of teams tasked with establishing customer needs, developing new products, and/or modifying existing designs.

The selected candidate will be the sole QA person for this project. This role will support the design team but will not directly engage in design work. Instead, the focus will be on quality assurance, validation, and risk management at the project level. This project supports the redesign of a commercial product for US, China and Japan markets.

DUTIES & RESPONSIBILITIES:

• Ensure compliance with Design Control and Risk Management activities and processes, managing and completing Quality deliverables for R&D projects.
• Provide Quality support and guidance to R&D project leads and team members, and direct Design Quality Engineers and Quality Engineers.
• Resolve project issues through collaboration with team members, suppliers, and other stakeholders, applying systematic problem-solving methodologies.
• Manage and maintain records related to design control projects, participate in design review meetings, and generate risk management file documents.
• Develop and review protocols and reports for sterilization, biocompatibility, and packaging validations, as well as review and approve R&D batch details and production records.
• Monitor data from Quality Management systems, provide immediate feedback on deviations or issues, and lead or facilitate compliance and improvement activities (e.g., CAPA/non-conformance).

REQUIRED QUALIFICATIONS:

• Minimum education of degree in a technical field is preferred.
• Minimum 5 years’ experience in the medical device industry and/or IVD/pharmaceutical, with at least three years in a position with direct responsibility for QMS processes/sub-processes.
• Demonstrated knowledge of the application of the principles, concepts and practices of design control, sterilization and Quality Assurance processes.
• Experience in preparation, participation and response to external agency inspections e.g. FDA and Notified Body Inspections
• Thorough knowledge of Design Control requirements and processes.
• Working knowledge of 21 CFR 820, ISO13485 with familiarity of other foreign medical device quality system requirements.
• Ability to handle multiple projects simultaneously and to discern major quality issues.
• Ability to work well under deadlines and pressure.
• Ability to work on own initiative and as a team player.
• Ability to build good, strong and positive working relationships with cross functional teams internationally.
• Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.

Apply today and start your fulfilling career!

Step into a world-renowned international organization where innovation is at the core of everything they do. This is your chance to support high-level Project Managers in the R&D division, playing a vital role in supporting strategic decision-making and driving impactful projects that change lives around the world

Why Choose This Role

• Collaborate with a prestigious global company
• Gain hands-on experience supporting complex projects, a fantastic opportunity for anyone interested in expanding their project management knowledge
• Perfect for those with a coordination background or junior project managers seeking exposure and growth
• Flexibility to work on a project of initially 12 months + possible extension

What to Expect

• The projects you’ll help support are challenging and success here depends on a proactive, resourceful approach
• Our client provides initial training on procedures and team structure, but they value someone who can work independently, find information, and deliver solutions
• The position is primarily focused on coordination and administration tasks, so if this isn’t your strength or interest, this may not be a suitable

Key Responsibility

• Support key project Managers during their projects.
• Maintain and update documentation, templates, and project standards
• Support project managers with scheduling, meeting coordination, and project documentation
• Ensure compliance with PMO methodologies, governance frameworks, and processes
• Track progress, risks, issues, and actions for R&D projects and track invoices
• Prepare regular status reports, dashboards, and executive summaries
• Act as a central point of communication between teams and stakeholders
• Organize PMO meetings, steering committees, and workshops, document decisions and follow-ups
• Maintain and support the use of PMO tools (MS Project, SharePoint, Planner)

Qualifications & Experience:

• Bachelor’s degree in business administration, Project Management, or related field
• 2–4 years’ experience in a PMO, project support, or coordination role
• Strong Microsoft 365 skills (Excel, PowerPoint, Project, Share Point)

Best if: Familiarity with project management methodologies (PRINCE2, Agile etc.)

Key Competencies:

• Exceptional organizational and time-management skills
• Strong communication, coordination, and stakeholder management abilities
• Attention to detail, accuracy, and analytical thinking
• Ability to manage multiple priorities in a fast-paced environment

The Country Manager will be responsible for establishing, developing, and leading operations in the specified country. This role will ensure the successful execution of European strategy at the local level, with a focus on driving adoption, reimbursement, and sustainable market growth. This role combines strategic leadership and hands-on operational execution, balancing business development, stakeholder engagement, and cross-functional coordination with medical, market access, and marketing teams.

As the local business leader, this role will act build trusted relationships with hospitals, laboratories, payers, clinicians, and institutional partners, as well as driving local performance, ensuring compliance with corporate standards, and contributing to European growth through strategic insights and operational excellence.

Responsibilities:

Strategy and Leadership

• Develop and execute the national business plan, ensuring alignment with European and global objectives.

• Lead and execute local launch and commercial expansion activities, from awareness building to full-scale adoption and reimbursement.

• Define and deliver measurable success metrics, including adoption milestones, reimbursement status, and revenue growth.

• Represent company as the senior company representative in the country, strengthening the organization’s visibility and credibility.

• Contribute to the European strategy by sharing local insights, opportunities, and competitive intelligence.

Market Development and Access

• Partner with the European Market Access Manager to support and lead national reimbursement applications, health technology assessments (HTA), tenders, and payer interactions.

• Establish relationships with national healthcare authorities, policy makers, and payer organizations to secure sustainable access.

• Identify and prioritize key institutions and clinical networks for product implementation, working closely with laboratory and hospital stakeholders.

Medical and Scientific Collaboration

• Work with the European Medical Director and local MSLs to support clinical collaborations, investigator-initiated trials, and local data generation.

• Engage with key opinion leaders (KOLs), scientific societies, and patient advocacy groups to advance the clinical and guideline integration.

• Ensure alignment between scientific messaging and commercial communication to maintain medical integrity.

Commercial and Marketing Execution

• Drive country-level growth through effective engagement with hospital networks, diagnostic laboratories, and pharmaceutical partners.

• Collaborate with the European Marketing Manager to adapt and implement marketing campaigns, congress activities, and educational initiatives tailored to local needs.

• Support internal and external training activities to ensure consistent messaging and product understanding.

• Monitor market dynamics, competitor activities, and regulatory developments, translating insights into actionable strategies.

Team and Operational Management

• Lead local team and partner with cross-functional stakeholders to build, manage, and develop the partner network (commercial, MSL, consultants, distributors) as required.

• Lead or coordinate tender responses and procurement processes in alignment with European Market Access.

• Ensure compliance with corporate standards, ethical policies, and local legal and regulatory requirements.

• Manage local budgets and resources efficiently to achieve performance objectives.

Position Requirements:

• Bachelor’s degree in Life Sciences, Business, or related field + 15 years of related experience. Prefer Master’s degree (MBA, MSc) + 14 years related experience or PharmD degree + 10 years related experience preferred.

• Minimum of 9 years’ experience in biotech, diagnostics, or pharmaceutical industry, including leadership of local operations or business units.

• 4+ years supervisory experience

• Proven track record in launching and scaling innovative healthcare or diagnostic products.

• Strong understanding of the local healthcare system, reimbursement environment, and stakeholder landscape.

• Experience managing cross-functional collaboration (medical, access, commercial, marketing) within a matrix organization.

• Strong leadership, negotiation, and communication abilities.

• Strategic thinker with an entrepreneurial mindset and operational execution skills.

• Proven ability to build relationships with external partners and internal teams.

• High integrity and commitment to compliance and ethical standards.

• Fluency in English and the local language is required.

Location: Leeds, United Kingdom

Employment Type: 12 months Full-time, On-site (with some flexibility)

Our client, a global leader in the medical device industry, is seeking a motivated Test Technician / Test Specialist to join their product testing and verification team in Leeds. This is an exciting opportunity to work hands-on with cutting-edge medical technologies, collaborating closely with experienced engineers and scientists in a highly regulated, innovative environment.

This position is ideal for professionals aiming to advance toward roles such as Product Test Engineer, Verification & Validation (V&V) Engineer, or Mechanical Test Engineer. It offers valuable exposure to product lifecycle development, ISO/FDA compliance, and computational modelling as part of the verification process.

Key Responsibilities

• Plan, coordinate, prepare, and execute mechanical product tests in collaboration with Senior Test Engineers.
• Conduct routine and complex mechanical and functional testing activities independently, ensuring adherence to SOPs, ISO standards, and FDA/UK regulatory requirements.
• Evaluate and interpret test data, prepare test protocols and reports, and maintain records within laboratory information management systems (LIMS).
• Support the development and validation of new test methods, and contribute to the creation and revision of standard operating procedures (SOPs).
• Utilise computational modelling and simulation tools to support test planning, data interpretation, and product performance prediction.
• Maintain and update test documentation within the document management system.
• Collaborate with R&D, Quality, and Manufacturing teams to ensure all testing deliverables meet project timelines and regulatory standards.
• Participate in continuous improvement initiatives, driving efficiency, accuracy, and innovation in the test environment.

Profile & Qualifications

• Completed apprenticeship (e.g. Mechanical / Laboratory Technician) or Bachelor’s/Master’s degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or a related discipline.
• 1–2 years of relevant experience in product testing, verification & validation (V&V), or medical device testing.
• Hands-on experience with mechanical testing equipment, measurement tools, and data acquisition systems.
• Exposure to or interest in computational modelling (e.g., FEA, CFD, or other simulation tools) is strongly preferred.
• Working knowledge of ISO 13485, ISO 14155, or FDA 21 CFR Part 820 standards is an advantage.
• Strong attention to detail, analytical thinking, and problem-solving skills.
• Excellent written and verbal communication skills in English.
• Proactive, team-oriented mindset with the ability to work effectively in a fast-paced and regulated environment.

What’s Offered

• Opportunity to work for a world-class medical technology company developing life-changing products.
• Competitive salary and comprehensive benefits package.
• Professional development opportunities and hands-on training in verification, validation, and computational modelling.
• Collaborative, inclusive, and innovation-driven culture with a focus on quality and continuous improvement.

Location: Zaventem, Belgium

Contract: 12 months with possible extension (Start from March-April 2026)

Kelly FSP is seeking a Clinical Submission Specialist to support one of the world's top five pharmaceutical companies in the medical devices sector. This role involves coordinating and preparing regulatory submissions to ensure compliance with global regulatory requirements for medical devices.

Key Responsibilities:

• Prepare and submit documents for EC/CA in the assigned region.
• Initiate and review translations of documents (e.g., Patient Informed Consent).
• Adapt Country/Site Specific Patient Informed Consent forms according to regulatory and EC requirements and obtain internal approval.
• Interpret clinical study protocols for EC/CA submission using layman terms where necessary.
• Act as the primary point of contact for EC/CA.
• Support document adaption per EC/CA requirements and manage responses.
• Assist in budget adaptation to meet country and site requirements.
• Maintain local regulatory documents and ensure they are uploaded to data management systems where applicable.
• Provide support to CSL and Clinical Project Teams.
• Assist in developing and reviewing informed consent documents to ensure all required elements are included.
• Support site activation document collection and approval processes.
• Attend, schedule, and document project-related meetings.
• De-identify and file adverse event source documents if applicable.
• Maintain the Clinical email box and disseminate emails appropriately.
• Support team personnel with site activation and closure activities.

Qualifications:

• 3-7 years of clinical submission experience across multiple EMEA regions.
• Must be familiar with submission processes across EMEA countries (Southern Africa, Israel, Eastern Europe are a plus).
• Effective phone communication skills are essential; candidates must be comfortable managing calls with authorities.
• Proficiency in English is required.
• Familiarity with cardiac, vascular, and/or neuromodulation technologies and clinical research processes is beneficial.
• Strong verbal, written communication, and interpersonal skills.
• Ability to work in a fast-paced, changing environment and within a geographically diverse business model.
• Strong organizational skills and ability to prioritize tasks to meet deadlines.

Location: EU remote

Contract: 12 months with possible extension

Are you ready to take your statistical programming career to the next level? Join us as a Principal Statistical Programmer where you’ll play a key technical and strategic role across multiple clinical studies and post-marketing projects. You'll work hands-on with advanced analytical techniques, lead programming efforts, and collaborate with cross-functional industry leaders to deliver high-quality results that support patient safety, drug efficacy, and regulatory success.

What You'll Do

· Lead Statistical Programming: Be the main programming expert for assigned studies, working closely with sponsors and internal teams to drive project success.

· Develop Reliable Analyses: Create and validate SAS programs for analysis datasets (ADaM), tables, listings, and figures that underpin clinical study reports, interim analyses, and exploratory data reviews.

· Champion Quality and Compliance: Review and oversee statistical deliverables from external partners to ensure accuracy and regulatory alignment.

· Shape Regulatory Submissions: Prepare submission-ready documentation (define.xml, annotated CRFs, Reviewer’s Guides), and collaborate on pooled analyses for integrated safety & efficacy summaries.

· Collaborate and Communicate: Work alongside biostatistics, data management, and medical writing teams to meet project timelines and deliverables.

· Promote Process Improvement: Streamline and automate workflows using tools like R, Python, or metadata frameworks.

· Mentor and Inspire: Support junior programmers, fostering growth in statistical programming and data analytics.

· Ensure Audit Readiness: Maintain top-quality documentation and compliance with industry standards and best practices.

Who You Are

· Experienced Programmer: Master’s degree (7+ years) or Bachelor’s (9+ years) in Statistics, Computer Science, or a related field, with hands-on experience in clinical trial statistical programming.

· CDISC Expert: Deep knowledge of SDTM and ADaM standards and submission processes.

· Analytical Leader: Proven ability to handle ad-hoc and exploratory analyses, and support publication and regulatory responses.

· Collaborator: Strong communication skills and experience leading projects and managing deliverables from external providers.

· Tech-Savvy: Experience with Pinnacle 21, Define.xml, and data visualization platforms (Spotfire, R Shiny) is a plus.

· Innovator: Familiarity with R or Python for automation and statistical programming is highly desirable.

Why Apply?

Here, you’ll have the chance to make a meaningful impact, mentor others, and innovate in a dynamic and supportive environment. If you’re ready to lead, collaborate, and help shape the future of clinical research, we want to hear from you!