Ignite Innovation in Advanced Therapies: Post-Market Clinical Follow-Up (PMCF) Specialist
Are you ready to shape the future of patient care?
Our client is a global leader and pioneer in the cutting-edge field of advanced therapies, with a deep commitment to the development and delivery of groundbreaking cell therapies, particularly within the high-impact CAR-T domain. They stand at the very forefront of innovation, operating in a dynamic, fast-paced, and highly collaborative environment. If you thrive on scientific excellence, regulatory rigor, and the opportunity to make a tangible difference in patient outcomes through a robust, globally integrated operational framework, this is your chance.
We are seeking a detail-oriented and analytical professional to join the team as a PMCF Specialist to ensure the continued safety and performance of their life-changing products in line with stringent international regulations.
What You Will Do: Key Responsibilities
As the PMCF Specialist, you will play a crucial role in ensuring post-market compliance and the continuous clinical evaluation of our client's advanced therapy products. Your core focus will be the coordination and documentation of Post-Market Clinical Follow-up activities.
PMCF Documentation Leadership:
* Draft, maintain, and own the PMCF Plans and comprehensive PMCF Evaluation Reports.
PMS and Clinical Evaluation Support:
* Actively support the optimization of the PMCF process (SOP/templates), integrating it seamlessly into the broader Post Market Surveillance (PMS) system to keep the Clinical Evaluation up-to-date.
* Review and contribute to Periodic Safety Update Reports (PSURs), ensuring complete alignment with PMCF findings.
* Critically review and contribute to key clinical documentation including Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Summaries of Safety and Clinical Performance (SSCPs), and the State of the Art (SoA) Protocol and Report, always ensuring alignment with PMCF data.
Data Collection & Analysis:
* Assist in the robust analysis and interpretation of collected data to accurately assess product safety and performance.
* Contribute to PMCF Evaluation Reports by concisely summarizing findings and their clinical relevance.
Regulatory Compliance:
* Maintain meticulous documentation required for audits, inspections, and global regulatory submissions.
* Prepare for, assist in, and attend regulatory audits/inspections where relevant.
* Collaborate cross-functionally to effectively address and resolve feedback received from Notified Bodies and Competent Authorities.
Cross-Functional Collaboration & Training:
* Work closely with internal Clinical Research teams (including other J&J MedTech Operating Companies), Scientific Operations, Regulatory Affairs, Medical Affairs, and Post-Market Surveillance to achieve project goals.
* Support essential training and awareness initiatives related to PMCF to foster optimal cross-departmental collaboration.
What You Bring: Required Skills and Experience
Necessary Skills:
* Exceptional Writing & Analytical Skills: The ability to translate complex data and regulatory requirements into clear, precise, and professional documentation.
* Unwavering Attention to Detail: A critical eye for accuracy and completeness in all documentation and processes.
* Conceptual Connector: Proven ability to connect insights across different data sources and synthesize input from various cross-functional stakeholders.
Preferred Experience:
* Proven experience in the Medical Devices or Advanced Therapies sector.
* Demonstrable experience with Post-Market Clinical Follow-Up (PMCF) activities.
* Familiarity with the Medical Device Regulation (EU) 2017/745 and relevant guidance documents such as MDCG 2020-6/7/8 is highly valued.
* Experience with Medical Writing for regulatory or clinical purposes.
What We Offer: Your Career and Benefits
This role is a unique opportunity to advance your career in a sector that is fundamentally changing medicine. You will be employed via a Randstad Professional contract, which offers the stability and growth opportunities of a trusted global partner.
Your attractive salary package and benefits as a Randstad Professional Consultant include:
* Competitive Gross Salary: Dependent on your personal experience and profile.
* Net Allowance: An additional net allowance of €80 per month, on top of your net salary.
* Mobility Choice: The possibility to opt for a company car (under conditions) with an all-inclusive fuel card (also for private use), or a substantial mileage allowance.
* Financial Perks: Meal Vouchers and Ecocheques (€250 per year).
* Comprehensive Time Off: Full Holiday Pay and a 13th Month, plus 12 extra days off per year (ADV days).
* Security: Excellent Hospitalization Insurance with DKV and access to Pension Savings.
* Commitment to Growth: Access to numerous training courses, career development opportunities, and engaging activities to guide your professional journey.
Are you the PMCF expert ready to drive compliance and clinical evaluation for life-saving therapies? Apply now to join this trailblazing organization!