Regulatory Affairs Consultant -Clinical Investigations/ Medical Device

Job Overview Clinical Investigations Consultant works with a team to develop and execute international strategies and submissions for clinical investigations of medical device products.

The person in this role will support the development and creation of Clinical Investigation and Regulatory documents in accordance with European Medical Device Regulation.

Responsibilities Knowledge and understanding of proposed and current global regulations and guidance and the ability to relay the impact of such regulations and guidance internally and with our clients. Performing literature reviews for specific medical devices; Support for preparing, writing, editing, and reviewing regulatory (e.g. Clinical Evaluation Reports (CERs), clinical data reports or summaries) documents. Assisting and writing Clinical Evaluation Reports, analysis of product complaints and trends, collecting and analysing feedback from various sources to support the CER Ensures documents are produced in accordance with procedures, internal and external guidelines Knowledge of clinical regulatory requirements (ISO 14155: 2020) QualificationsRequirements Minimum of 5 years of experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation Experience with EU/FDA and international regulations, requirements and guidance associated with clinical regulatory document preparations, submissions and reporting preferred Bachelor level degree required preferably in engineering, chemistry, physics, biology or related life science Consulting experience preferred Project Management skills Fluent English