Clinical Affairs Officer
Clinical Affairs Officer
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Job Description
Job Description
Barrington Jamesis seeking aClinical Affairs Officerto join an innovative and fastgrowing 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:
- Conductscientific and competitive intelligence including literature reviews analysis of competitor products and maintaining a bibliographic repository.
- Develop and manageclinical safety documents such as Clinical Evaluation Reports (CER) and PostMarket Clinical Followup (PMCF) studies.
- Take ownership ofclinical studiesby designing protocols managing collaborations with CROs and analysing results.
- Support theregulatory affairsteam with product registrations and drafting essential clinical reports.
What Were Looking For:
- Abiomedical engineeringor 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 professionallevel English writing ability.
- A selfmotivated detailoriented 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 forwardthinking organisation. Youll work with cuttingedge technologies and have a meaningful impact on advancing healthcare.
To apply:
#LINF1
Required Experience:
Unclear Seniority
Employment Type
Full-Time
