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Regulatory Affairs Manager - Post Market Support - Essex - Southern

Excellent salary & benefits package - Regulatory
Ref: 97 Date Posted: Monday 23 Apr 2018
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Our clients Manufacturing Business Centre based in Essex, plays a key role in the development and manufacture of new, sophisticated medical and industrial products. Working with colleagues in Europe, the USA and Japan, our multi-disciplinary team of R&D engineers is fully equipped with the latest computer-aided design and modelling technologies, to enable them to develop medical workstations and fluid management products & accessories, and industrial Remote Visual Inspection devices.

Producing world-class products in terms of Quality, Cost and Delivery isn't just desirable, it's essential. Therefore, in today's fast-moving, ever-changing world, we continue to invest in both our people and the latest equipment and processes to remain at the forefront in manufacturing technology.

Responsibilities include:

  • Manage effective product postmarketing processes, ensuring all company regulatory and obligations are fulfilled.
  • Management of both the quality and regulatory aspects of customer complaints, vigilance reporting, field corrective actions and advertising and promotion processes.
  • Product recalls, training of employees in quality and regulatory requirements, managing and performing internal quality system audits, technical file review and global product registrations.
  • Performing audits of new suppliers, hosting external audits, coordinating QA/RA projects with partner companies.
  • Liaising with regulatory authorities and providing know-how on all matters relating to global quality and medical device regulations, including the defence of product liability claims
  • As the process owner, responsible for the concerns and field corrective action processes, ensuring they achieve performance expectations and reporting requirements. Lead necessary process improvement activities.
  • Provide leadership to the team and undertake the required HR responsibilities.
  • Hosting customer and regulatory audits as required.
  • Keep up to date on regulatory requirements and ensure processes are compliant.


To be successful in this role, you will need:

Degree, or equivalent, in an Engineering or Life-Sciences Discipline (or equivalent).

Five years in regulatory affairs specifically for Medical Devices development.

Experience in global submissions

Experience working in Post Market Support and Surveillance.

Proven track record in a supervisory role.

Specialists in consultancy

At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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