Mission:
Make a difference in patients' lives by ensuring our medical devices reach the market safely and effectively.
As a Clinical & Regulatory Affairs Specialist, you will play a crucial role in bringing our medical devices to market in compliance with national and international regulations. You will be involved in the entire product lifecycle, from its conception to post-market follow-up.
Responsibilities:
Regulatory Affairs:
- Act as “Person Responsible for Regulatory Compliance” (PRRC), in accordance with Article 15 of EU MDR 2017/745
- Manage activities and ensure regulatory compliance on assigned projects
- Ensure technical file compliance
- Supervise implementation and validate market surveillance activities (PSUR and SSCP)
- Prepare regulatory submission dossiers for new products, product change or license renewal
- Contribute to responses to notified bodies and competent authorities
- Monitor regulatory changes and ensure their application internally
- Respond to audits by notified bodies and competent authorities concerning regulatory aspects
Clinical Evaluation:
- Coordinate clinical evaluations with internal and external experts
- Consolidate evaluation plans and clinical evaluation reports (CEP, CER)
- Plan and conduct systematic literature reviews on relevant medical devices and clinical practices
- Ensure submission of clinical study reports to regulatory authorities
- Respond to audits for clinical aspects by notified bodies and competent authorities
Post market clinical follow-up:
- Define the PMCF plan, implement and monitor activities in collaboration with the various stakeholders (internal and external)
- Write the PMCF report
Profile:
- Master’s degree or equivalent qualification in life sciences, engineering or related field. A PhD would be a plus.
- At least 4 years' experience in clinical evaluations, medical writing or clinical research in the medical device sector.
- In-depth knowledge of national and international regulations applicable to medical devices (ISO 13485, MDR 2017/745, MDSAP, FDA, etc.)
- In-depth knowledge of systematic research of scientific literature, clinical research (clinical investigations) and medical writing
- Experience in Class III medical devices would be a plus
- Excellent written and oral communication skills
- Ability to work independently and as part of a team
- Strong analytical and statistical skills
- Fluent in English (B2 minimum), any other languages such as French or German is a plus
Our Benefits:
- Friendly, collaborative work environment in a family setting
- Variety of assignments
- Opportunity to contribute directly to the company's results and success
- Development and career opportunities
- Flexible working hours
Complete application dossier should be sent directly through Jobup.