Regulatory & Risk Manager
|Job Title:||Regulatory & Risk Manager|
|Location:||Birmingham, West Midlands|
|Contact Name:||Rachel Radford|
|Job Published:||February 08, 2017 15:05|
Your key responsibilities will include, but not be limited to
- To drive the company to deliver sufficient depth of evidence to demonstrate regulatory compliance.
- To drive the vigilance processes 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.
- Extensive experience working in product development & delivery.
- Sound technical knowledge of product base and application.
- Degree or equivalent experience in appropriate subjects.
For a confidential discussion about this role please call Rachel on +44(0)2033273072 or send your CV to firstname.lastname@example.org
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