Regulatory and Risk Manager
- Contract Type
We are currently working with a ground breaking medical device manufacturing company, who are in a state of growth and therefore looking to recruit a Regulatory and Risk Manager to their team based near Warwick. Your purpose in this role will be to develop a regulatory strategy to support all target markets, and to maintain regulatory compliance as required. You will be responsible to the Director of Quality and Regulatory Affairs.
Essential Candidate Experience:
?? Experience as a Regulatory Manager with ideally some team leading or management experience.
?? 510K and FDA submission experience
- To drive the company to deliver sufficient depth of evidence to demonstrate regulatory compliance.
- To drive the vigilance processes (PMS feedback, regulatory changes, adverse events, competitor information, literature searches) required in Europe, US and other relevant markets.
- To deliver PMS report, Vigilance Report and clinical evaluation report in line with the relevant plans.
- To define the appropriate regulatory pathways for entry into global markets and support other members of the company in understanding the regulatory pathways.
- To provide advice on possible approaches to de-risking and accelerating project completion.
- To provide advice on approaches taken by other companies for comparable products in satisfying regulatory requirements.
- To provide risk assurance support into the design and development process, to assure risk consideration and acceptability as ALAP throughout the product development lifecycle.
- To provide managerial leadership for RA team members, ensuring that there is a common agreement on strategy, priorities and deadlines, and to maintain a strong understanding of delivery against plans and targets.
- Strong understanding of regulatory standards and their implementation in a Medical Device framework i.e. Medical Device Directive (93/42EEC), ISO 13485, ISO 14971, IEC 60601, IEC 62366, IEC 62304, 21 CFR 820,21CFR 807, 21 CFR 11.
- Experience in working with PEMS (Programmable Electrical Medical Systems) or equivalent high-integrity software-intensive systems i.e. complex devices requiring multidisciplinary development effort (mechanical engineering, software, electronics, system integration, pneumatics, fluid mechanics, etc.).
- Experience of working with risk management, regulatory requirements, document management systems, issue management systems.
- Trained in application of IS014971.
- Ability to work with external bodies.
- Good team player and effective communicator.
- Flexible approach to hours.
- Ability to operate at strategic and operational levels.
- Ability to identify strategic and operational issues and develop plans to address.
- Ability to lead; demonstrating assertiveness, team building and management skills.
- Attention to detail.
- Effective communicator.
- Articulate, persuasive personality.
- Extensive experience working in product development & delivery.
- Sound technical knowledge of product base and application.
- Degree or equivalent experience in appropriate subjects.