- Compliance and approvals
- Malmesbury - United Kingdom
About the roleThe Medical and Clinical Affairs Manager will be ‘hands on’ and fully involved in all aspects of medical Affairs and Clinical Research for medical devices. The Medical and Clinical Affairs Manager will be responsible for the entire lifecycle of the product/ project including clinical projects, from concept and design of products through to claims, copy approval, expert engagement, clinical trials, ethics/ regulatory submissions, implementation, reporting, publications, post marketing activities including medical information and update of regulatory documents.
The role includes the creation of medical affairs and clinical SOPs, regulatory documents, developing and reviewing clinical documents.
Key Responsibilities of the Medical and Clinical Affairs Manager:
- Cross-functional working with internal functions/departments globally, including but not limited to: Engineering, Research, Commercial, Claims, Regulatory, Quality, Sensory and Manufacturing.
- Implement the Global medical/non-promotional strategy/plan for the respective product.
- Manage the safety evaluation and risk management for the respective product through its lifecycle including post marketing.
- Provide expert support relating to products, treatment trends, and scientific activities within therapeutic area for internal stakeholders and external professionals.
- Access promotional materials to ensure that all claims are supported by scientific data and presented in an accurate, fair, and balanced manner, ensuring compliance with SOPs.
- Develop and maintain direct contact with external experts to gather insights and input on treatments.
- Identification and liaison with relevant key opinion leaders (KOLs). Develop strong peer to peer scientific partnerships.
- Overall responsibility for setting the clinical strategy including clinical operations, with a focus on clinical investigations and evaluations for regulatory purposes and marketing trials.
- Responsible for interfacing with ethics committees and obtaining applicable ethics approval for proposed studies.
- Ensuring compliance with all relevant regulatory requirements in cooperation with Quality and Regulatory Affairs, the legal department and any relevant protocols set by the company.
- Provide adequate, maintained devices for clinical activities to meet the strategic goals of the Company.
- Work with Quality, Regulatory and Compliance departments to prepare documentation for submissions to obtain regulatory approval for commercialization of medical devices, supporting regulatory inspections/audits.
- Develop and implement clinical marketing plans for the respective project, serving as a relationship manager and spokesperson in clinical marketing and outreach activities.
- Reviewing, obtaining and providing medical, clinical and scientific input on content of device labelling and promotional material.
- Select and manage vendors to assist in necessary operational aspects of running clinicals as budget and resources permit.
- Lead the ongoing review of clinical trial data (as needed), analysis and interpretation including the development of first interpretable results, clinical investigation and evaluation reports, publications and internal/external presentations. Including post-market follow up studies.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable training will be made available to enable individuals to perform the essential functions.
- 5-10 years’ experience in the pharmaceutical, medical device or cosmetic sector.
- Science Degree or other relevant degree or qualification (PhD an advantage).
- Proven medical affairs/clinical research management/leadership experience (preferably within a medical device company).
- Knowledge and understanding of the regulatory process and associated governance of medical devices. A working knowledge of Medical Device and IVD Directives.
- Experience of US FDA regulations advantageous. Working knowledge of relevant international standards and guidelines.
- Occasional travel to conduct site visits, KOL engagement and research conferences would be required globally.
- Experienced in the use of the following:
- PAGB code.
- Quality Management Systems ISO 13485.
- ISO 14155: 2011* Clinical investigation of medical devices for human subjects - Good Clinical Practice.
- ISO 14791: 2012 * Risk Management
- IEC 62366:2015 Application of usability engineering to medical devices
- ICH GCP guidelines.
- Proven experience of managing clinical investigations and evaluations from planning, obtaining ethics committee approvals, implementation and successful completion.
- Medical writing and statistical analysis skills advantageous.
- Safety and Risk Management experience desirable.
- Knowledge of consumer products beneficial.
- 27 days holiday plus eight statutory bank holidays
- Pension scheme
- Performance related bonus
- Life assurance
- Free on-site parking
- Subsidized café
- Discounts on Dyson machines
- Private Medical and Dental
We are following the government guidelines regarding COVID19. At this time all interviews will be conducted via video or telephone. We’re taking these precautionary measures to protect both our employee and candidate wellbeing. Our Talent Acquisition team will work with you and provide further information as appropriate.