Clinical Specialist/Consultant – Medical Devices (PMS / PMCF / CER)
We are partnering with a growing medical device company seeking a hands-on Clinical Consultant with expertise in Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), and Clinical Evaluation Reports (CERs). This is an exciting opportunity to work ongoing projects and ensure compliance with MDR and FDA regulations.
Key Responsibilities:
* Develop, implement, and manage PMS and PMCF plans for medical devices.
* Prepare and maintain Clinical Evaluation Reports (CERs) in accordance with MDR and ISO 13485 requirements.
* Support clients with regulatory submissions and compliance for both EU MDR and FDA.
* Provide hands-on clinical and regulatory consultancy, reviewing safety, risk, and performance data.
* Collaborate with cross-functional teams, including RA/QA, engineering, and marketing.
* Stay up-to-date with global regulatory requirements and best practices in medical device clinical compliance.
Qualifications & Experience:
* Proven experience in PMS, PMCF, and CERs for medical devices.
* Strong knowledge of EU MDR, FDA, ISO 13485, and other relevant regulations.
* Hands-on clinical or regulatory experience in the medical device industry.
* Excellent analytical, communication, and project management skills.
* Able to work independently and with clients to drive actionable insights.
Why Join:
* Work with a dynamic organisation supporting innovative medical device companies worldwide.
* Opportunity to directly influence clinical and regulatory strategies for impactful medical technologies.
* Flexible and collaborative working environment.