Senior Clinical Affairs Specialist
il y a 18 heures
**Introductie**:
To reinforce our client's clinical affairs team we are looking for a Senior Clinical Affairs Specialist - Medical Devices.
**Jobomschrijving**:
Clinical Evaluation (35%)
- Develop and maintain Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs)
- Perform systematic literature reviews to support clinical evaluations and regulatory submissions
Post-Market Clinical Follow-Up (30%)
- Contribute to the development and execution of Post-Market Clinical Follow-Up (PMCF) plans and reports
- Collect, analyze, and interpret safety data, including trending and reporting
Clinical Studies (25%)
- Organize and manage clinical studies for both pre-market and post-market phases
- Coordinate study activities in compliance with applicable regulations and internal procedures
Collaboration (10%)
- Work closely with product managers, regulatory affairs professionals, and other team members to support clinical and regulatory strategies
**Profiel**:
- Experience in developing Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) in medical devices
- Strong skills in conducting systematic literature research
- Ability to develop and execute PMCF plans and reports
- Proficiency in safety data analysis and reporting
- Experience in organizing and executing clinical trials
- Excellent collaboration skills with cross-functional teams
- You are fluent in English
**Aanbod**:
- Gross monthly salary starting from €4500, based on your experience and profile
- Company car or mobility budget - your choice
- Group insurance and hospitalization insurance for peace of mind
- Net expense allowance to cover professional costs
- Meal vouchers to support your daily lunch breaks
- 33 vacation days per year for a healthy work-life balance
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