Clinical Affairs Officer
il y a 4 jours
**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
**Key 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.
**What We're Looking For**:
- 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:
**+44 1293 243 844**
**#LI-NF1
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