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.