Senior Regulatory Affairs Executive – Medical Devices

Attribute Value
Type Full time
Salary Competitive
Closing date 31 July 2018
Reference RG131HP

A bit about us

Regulis is a specialist consultancy company providing global Regulatory Affairs, Pharmacovigilance and Quality Assurance services. The company was formed in 2001 and since then has seen significant growth.  The company is built around a growing permanent team based in Hertfordshire, UK supplemented by an established global network of consultants to deliver high quality, customer-focussed solutions.

Our medical device clients range from large multinationals to small start-up companies, from low risk devices to innovative high risk devices, as well as drug-device combination products.

About the role

This is an exciting opportunity to join a dynamic and dedicated team at Regulis.  Within the Regulatory Affairs team you will be responsible for providing regulatory expertise in the development, registration and post-approval activities of medical devices and ensuring high quality and timely delivery of consulting services to clients.

You will work directly with clients, handling tasks with minimum supervision and interacting professionally at multiple levels within client organisations.

The position requires at least 3-4 years of experience in the medical devices field of regulatory affairs.  The role will also allow the right candidate to gain experience with medicines and drug-device combination products.

Candidates will need up-to-date knowledge on the current EU Medical Device Directive and upcoming changes in the Regulation. We will also require the candidate to have a good working knowledge of ISO 13485 and have experience in maintaining a Quality Management System for a medical device portfolio. You will also have good technical writing skills and be confident in preparing documents such as clinical evaluation reports, risk management plans and device labelling.

This is an excellent opportunity for a talented, independent and self-motivated regulatory professional to join a team that will not only provide you with a wide variety of experience in regulatory projects, it will also give you all the support you need to develop your regulatory career.

Key highlights

  • Exposure to a wide variety of medical device projects (class I to III)
  • Forging strong relationships with clients and regulatory agencies
  • Being part of a small, high performing team
  • A rare opportunity to get involved in medical devices, medicines and borderline projects
  • The opportunity to play a part in growing and enhancing the strong reputation the company already has in the regulatory industry.

Your profile

  • Life Sciences Graduate or Pharmacist, ideally with a post-graduate qualification
  • At least 3-4 years’ experience in the medical device industry
  • Sound knowledge of the medical device Directive/Regulation and MEDDEV guidelines
  • Good regulatory affairs experience including a successful track record in writing medical device technical files

You will be expected to work independently on a day-to-day basis, have excellent written and verbal communication skills, good organisational and analytical skills, as well as excellent attention to detail.  The successful candidate will also be fluent in written and spoken English.

What we offer

  • A competitive salary (depending on experience)
  • Benefits that include 25 days’ holiday, pension, life assurance, option to buy or sell additional holiday, childcare vouchers, fruity Tuesdays, early finish on Fridays and an annual bonus and salary review
  • Ongoing training and support
  • The chance to be part of a TOPRA award winning consultancy that will help you to grow and build on your current experience aligning your career goals and aspirations with that of the company
  • A strong team ethic with regular events organised
  • Modern newly refurbished office in a town centre location with parking facilities.

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