Medical Devices Regulatory and Risk Manager (ISO13485, 510(k))
£Neg + benefits
This is a fantastic opportunity to join a fast growing, innovative, high technology medical devices company, developing an advanced system for use both in the home and in medical centres that will significantly improve the quality of life of the patients involved. The product is unique and set to make a significant impact on a multi-billion dollar global market. The company now requires an experienced Regulatory and Risk Manager to develop a regulatory strategy to support all target markets, and to maintain regulatory compliance as required.
- 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.