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Clinical Specialist X 2

As a Clinical Specialist, you will lead and co-ordinate medical affairs activities on a project basis. You will act as a medical affairs representative and will provide expertise for a variety of different areas and functions, including but not limited to; product change control activities, risk management activities (e.g. Product Risk Reviews), complaint evaluations, Health Hazard Evaluation (HHE) preparation and more. Some of your main duties and responsibilities include:

Represent medical affairs on core/project teams for product development and change control including risk assessments and IFU development. Review and provide input into design history file remediation activities including design verification/validation, hazard analyses, and product risk reviews
Review and approve documents from a medical perspective which include, but are not limited to: Clinical Research Protocols, Clinical Study Reports, and Clinical Evaluation Reports
Provide medical input into Health Hazard analyses
Provide medical review support for Medical/Regulatory/Legal (MRL) approval for advertising and promotional material. Working closely with core/project team members to ensure claims and intended use are accurately represented
Support the complaint handling group, participating in Medical Device Complaint/Malfunction review, ensuring appropriate assessment and guidance in terms of reportability as required
Consulted for input on the following activities including but not limited to: country and site selection, investigator meetings,
Communicates and works closely with other departments such as R&D, Regulatory Affairs, Quality Management and Marketing to ensure timely completion of medical affairs documents for Regulatory filings and medical responses to health authorities.
Leads ad-hoc strategic projects.
Additional activities include supporting medical information request, medical training, KOL management, support to the local commercial business unit team, support for organizing advisory boards, aligned with the Medical Affairs Director AWC.As the ideal candidate, you will have a minimum of a bachelor's degree in a relevant life science discipline and wound care experience. You will have a full understanding of the product development process, the medical device industry and of the pre-clinical, clinical, marketing, and regulatory components. You will need great communication skills, a pro-active and result-driven work ethic and efficient time management
Leeds, United Kingdom, gb