Clinical Affairs Officer

Barrington James Limited; Bourgogne-Franche-Comté; Sur place; EUR 20 000 - 40 000; Plein temps

Résumé du poste

A leading medical device organization in Bourgogne-Franche-Comté is seeking a Clinical Affairs Officer to oversee clinical studies and regulatory activities. Ideal candidates will have a background in biomedical engineering and at least 2 years of relevant experience. The role involves conducting competitive intelligence and supporting regulatory teams. This is an opportunity to make a significant impact in healthcare while working with innovative technologies.

Qualifications

• At least 2 years of experience in clinical and regulatory affairs for medical devices.
• Familiar with medical device regulations (MDD/MDR, ISO 14971, ISO 13485).
• Self-motivated and detail-oriented.

Responsabilités

• Conduct scientific and competitive intelligence.
• Develop and manage clinical safety documents.
• Design clinical study protocols and manage collaborations.
• Support the regulatory affairs team.

Connaissances

Biomedical engineering or health/biomedical background

Expertise in clinical document drafting

Strong bibliographic research skills

Professional-level English writing

Good analytical skills

Formation

Graduate in biomedical engineering or health/biomedical field

Description du poste

Overview

Barrington James is seeking a Clinical Affairs Officer to join an innovative and fast-growing medical device organisation. This role offers the opportunity to take ownership of clinical and regulatory activities, making a real impact in the healthcare industry!

Responsibilities

• Conduct scientific and competitive intelligence, including literature reviews, analysis of competitor products, and maintaining a bibliographic repository.
• Develop and manage clinical safety documents, such as Clinical Evaluation Reports (CER) and Post-Market Clinical Follow-up (PMCF) studies.
• Take ownership of clinical studies by designing protocols, managing collaborations with CROs, and analysing results.
• Support the regulatory affairs team with product registrations and drafting essential clinical reports.

Qualifications

• A biomedical engineering or health/biomedical graduate with at least 2 years of experience in clinical and regulatory affairs for medical devices.
• Expertise in drafting key documents (CER, PMCF, PSUR) and knowledge of medical device regulations (MDD/MDR, ISO 14971, ISO 13485).
• Strong bibliographic research and analytical skills, with professional-level English writing ability.
• A self-motivated, detail-oriented individual with a curious mindset and excellent communication skills.

This is a unique opportunity to take full ownership of clinical and regulatory functions within a forward-thinking organisation. You’ll work with cutting-edge technologies and have a meaningful impact on advancing healthcare.

To apply:

[e-mail]

[phone]

#LI-NF1