The PMCF team operates as a focused unit within the clinical organization, separate from pre-market and post-market teams. The focus aligns with Medical Writing and Regulatory activities; it is not a project management role and does not oversee clinical study execution.
Scope and responsibilities
- Drafting and reviewing PMCF Plans and PMCF Evaluation Reports
- Supporting PMS and clinical evaluation documentation (CEP, CER, SSCP, PSUR, State-of-the-Art)
- Reviewing and aligning cross-functional scientific and regulatory inputs
- Analysing PMCF data and formulating evidence-based safety and performance conclusions
- Ensuring compliance for audits, inspections and regulatory submissions
- Acting as liaison for investigator-sponsored studies when applicable
- Implementing study-relevant parameters, deliverables, documentation standards and compliance requirements
- Contributing expertise in cross-functional discussions on new product concepts and business strategies
- Assessing internal and external clinical proposals linked to company objectives
- Providing scientific and regulatory rationale to reduce risk and improve clinical-evidence quality
- Preparing or supporting required documentation for regulatory filings and reporting
- Collaborating with Clinical Research, Scientific Operations, Regulatory, Medical Affairs and PMS teams
Qualifications:
- Proven first experience in PMCF
- Familiar with Medical Device Regulation (EU) 2017/745 and MDCG 2020-6/7/8
- Strong writing and analytical skills
- Attention to detail
- Connecting the dots across different sources and cross-functional inputs
- Experience in Medical writing preferred; review-only experience can be relevant
What we offer:
- We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, full electric company car and charging card, hospitalization and groups insurance, lunch vouchers, eco vouchers, mobile phone (data included)
- We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, …)
- Side activities will be organised regularly, to achieve a close collaboration within our team
- We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.
- We contribute to a number of charities & support the research and / or the patients in our industry.