Senior Medical Device Regulatory Affairs and Standardization Specialist

KARPOS RH is recruiting on behalf of one of its clients, an R&D center specializing in the development of medical devices and innovative healthcare technologies, for a Clinical and Post-Market Surveillance Specialist.

Reporting to the Research & Innovation Director, you will join the team to support one of the company’s key strategic clients in the development of innovative healthcare solutions.

You will be responsible for clinical evidence generation, Post-Market Surveillance (PMS) activities, and Post-Market Clinical Follow-Up (PMCF) programs, ensuring the safety, performance, and regulatory compliance of the company’s products.

In this role, you will actively contribute to the preparation and maintenance of Clinical Evaluation Reports (CERs), Post-Market Surveillance (PMS) activities, Post-Market Clinical Follow-Up (PMCF) programs, Periodic Safety Update Reports (PSURs), and the technical documentation required under the European Medical Device Regulation (EU MDR).

Key Responsibilities :

• Lead the preparation, maintenance, and updating of Clinical Evaluation Reports (CERs) in accordance with EU MDR Annex XIV and MEDDEV 2.7/1 Rev.4.
• Perform systematic literature reviews, clinical data evaluations, and state-of-the-art assessments.
• Develop and maintain Clinical Evaluation Plans (CEPs) and clinical evidence generation strategies.
• Manage Post-Market Surveillance (PMS) activities across the entire product portfolio.
• Collect, review, analyze, and trend complaints, customer feedback, vigilance data, scientific literature, and distributor feedback.
• Prepare PMS Plans, PMS Reports, PSURs, Trend Reports, and Benefit-Risk Evaluations.
• Develop and maintain PMCF Plans and PMCF Evaluation Reports.
• Coordinate PMCF studies, surveys, registries, and Real-World Evidence (RWE) initiatives.
• Support vigilance assessments, complaint trending analyses, and field safety evaluations.
• Ensure consistency between PMS activities, CERs, PMCF programs, and risk management documentation.
• Provide clinical expertise for MDR technical documentation and regulatory submissions.
• Support audits, inspections, Notified Body reviews, and interactions with regulatory authorities.
• Monitor updates to EU MDR, MDCG guidance, ISO standards, and clinical requirements, assessing their impact on the business.
• Collaborate closely with Quality, Regulatory Affairs, R&D, Medical Affairs, Marketing, and Commercial teams.