Regulatory and Risk Manager

Recruiter
Verelogic IT Recruitment
Location
Warwickshire
Posted
12 Aug 2017
Closes
20 Sep 2017
Sector
General
Contract Type
Full Time

Overview:

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

Key Responsibilities

  • 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.

Requirements/Qualifications

  • 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.