Documentatiespecialist

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