Regulatory Affairs Manager – Medical Devices

Attribute Value
Type Full time
Salary Competitive
Closing date 5 July 2019
Reference RG135

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- focused solutions.

 

Our clients range from large multinationals to small start-up companies, with low-risk and high-risk medical devices in their portfolios.

About the role

In this management position you will be expected to line-manage a small team of permanent regulatory professionals and together, manage a portfolio of clients and projects, working to often tight deadlines. At Regulis, you will be expected to apply your regulatory know-how and experience by working independently to take the lead on some of our more interesting and challenging projects. The successful candidate will be expected to join the team and ‘hit the ground running’ with the device regulatory projects. If this is your first step into a team management position you will be provided support and guidance for you to grow into the role. The candidate will be expected to support the Managing Director with business development opportunities by building strong relationships with new clients and maintaining relationships with existing clients.

You will work directly with clients, managing projects with a significant degree of autonomy and independence, and interacting professionally at multiple levels within client organisations and with Regulatory Agencies.

The position requires at least 5 years’ experience in the medical devices area of regulatory affairs.

The successful candidate will have strong experience with different types of medical devices. Knowledge on class III devices is highly desirable, but not essential. The candidate will be confident with their technical knowledge on the current EU Medical Device Directive and be up to date on the changes required under the Medical Device Regulation. The candidate must have a good working knowledge of ISO 13485 and how to implement or maintain the system.

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 the support you need to develop your regulatory career in the areas outlined above.

Key highlights

  • An opportunity to combine more complex regulatory project work and line management in one role
  • An opportunity to work on a diverse range of devices and clients
  • Forging strong relationships with clients and regulatory agencies
  • Being part of a small, high performing team
  • 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 5 years’ experience in the medical devices area of regulatory affairs.

To succeed in this role you will require strong project management skills, excellent written and verbal communication skills, good organisational and analytical skills, a proactive approach, be able to work quickly and effectively under pressure, and be an outstanding team player. The successful candidate will also be fluent in written and spoken English. Strong and demonstrable technical writing skills are a must.

What we offer

  • A competitive salary (depending on experience)
  • Benefits that include 25 days’ holiday, company pension scheme, life assurance, the option to buy or sell additional holiday, childcare vouchers, ‘fruity’ Tuesdays, an early finish on Fridays and an annual bonus and salary review.
  • Ongoing training and personal development 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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