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Regulatory & Risk Manager

Regulatory & Risk Manager

Job Title: Regulatory & Risk Manager
Contract Type: Permanent
Location: Birmingham, West Midlands
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: HQ00050517_1493804467
Contact Name: Rachel Radford
Contact Email: r.radford@sciproglobal.com
Job Published: May 03, 2017 10:41

Job Description

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.

Key requirements

  • 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.

If this sounds like you please don'thesitate to apply today!