Regulatory And Risk Manager

ARM Manufacturing & Technologies
60000.00 GBP Annual
07 Aug 2017
22 Aug 2017
Job Type
Contract Type
Regulatory and Risk are a crucial and important part of the production of Medical Devices to ensure efficient patient care. With an increase in demand for their dialysis products, my client are now seeking a Regulatory and Risk manager to support and maintain the regulatory and compliance in relation to legislation requirements for PEMS / Programmable Electrical Medical Systems

Regulatory and Risk Manager

What will you be doing?

- Drive the company to deliver sufficient depth of evidence to demonstrate regulatory compliance.
- Drive the vigilance processes (PMS feedback, regulatory changes, adverse events, competitor information, literature searches) required in Europe, US and other relevant markets.
- Deliver PMS report, Vigilance Report and clinical evaluation report in line with the relevant plans.
- Define the appropriate regulatory pathways for entry into global markets and support other members of the company in understanding the regulatory pathways.
- Provide advice on possible approaches to de-risking and accelerating project completion.
- Provide advice on approaches taken by other companies for comparable products in satisfying regulatory requirements.
- Provide risk assurance support into the design and development process, to assure risk consideration and acceptability as ALAP throughout the product development life cycle.
- 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.

About you.

- 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.

Location: Alcester, Warwickshire
Please contact Zara Riley on ************ for more information

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