Clinical and Regulatory Affairs Manager

We are supporting one of our clients in the search for an experienced Clinical and Regulatory Affairs Manager for a long-term consulting assignment. The ideal candidate will bring strong expertise in Clinical Evaluation Reports (CER) for implantable medical devices and will work closely with cross-functional teams based in Geneva.

Key Responsibilities:

• Authoring Clinical Evaluation Reports (CERs) for implantable medical devices

• Supporting clinical submissions to regulatory authorities

• Contributing to the preparation of annual Periodic Safety Update Reports (PSURs)

• Assisting with administrative aspects of clinical and regulatory documentation (CERs, PSURs, etc.)

• Participating in internal process improvement initiatives

Profile:

• A recognized qualification in a clinical or medical field

• At least 5 years’ experience in clinical evaluation writing in medical devices field, ideally in the field of orthopaedic surgery

• Strong knowledge of the EU MDR 2017/745 regulatory framework

• Excellent organizational and interpersonal skills

• Fluency in both French and English

Additional Information:

• This is a full-time consulting mission

• 4 days per week on-site in Geneva

• Initial contract duration: 2 years

If this opportunity matches your profile and career goals, feel free to get in touch confidentially for more information.