Regulatory Affairs Manager - South UK - Home flexibility - Hampshire

Circa £60,000 per annum plus benefits - Regulatory Affairs - Devices - Regulatory Affairs
Ref: 10 Date Posted: Tuesday 16 Jul 2019
LinkedIn ShareShare
More

Regulatory Affairs Manager – Medical Devices

South UK - Home-based flexibility

Circa £60k

 

An opportunity for a Regulatory Affairs professional who has proven experience to a specialist/manager level looking to build and lead within an expanding team.

 

Our client is an established, international medical device company with an excellent range of active Class IIA/B and III products sold globally.

 

They are looking to secure a RA Manager in an expanding regulatory team in a truly progressive role.

 

Our client offers an excellent salary and market leading benefits package as well as a culture that allows for flexible part-home, part-office flexibility – please call for location and salary package details.

 

This RA Manager position reports to the Global Regulatory Affairs & Quality Assurance Director with responsibilities for global registrations for a range of products including active (electronic/software) medical devices.

 

Position:

Regulatory Affairs Manager – Medical Devices

 

Salary:

Up to circa £55,000 - £60,000 per annum plus benefits – please call for details

 

Location:

Hampshire – ideal for someone residing in or near the areas of Hants, Berkshire, Oxfordshire, Surrey, Sussex, South / West London, M3 Corridor, Winchester, Southampton, Guildford, Reading, Newbury, Farnham, Basingstoke, Aldershot, Farnborough, Fleet, Bracknell, Woking, Camberley, Andover. Or for a RA Specialist looking to relocate.

 

Job role:

Our client is expanding their Regulatory and Quality team and have created a new position for a Regulatory Affairs Manager within a progressive role which will advance to Regulatory Affairs Manager with team build and leadership responsibilities. Key focus within this role is for product registrations globally including Canada, Japan, China, Australia, Latin America and EU.

 

Ideal applicant:

Our client is looking to develop a RA Manager, the idea applicant will have proven experience within a medical device registrations role with circa 4-5 years’ experience (candidates with more or less will also be considered). Further key skills sought include;

  • Degree level education
  • Fully trained and up to date in the requirements of ISO 13485 2016
  • Trained in the requirements of MDR
  • Knowledge of the EU Medical Device regulations
  • Must have experience of Global Regulatory submissions
  • Electronic / software device experience – ideal but not essential
  • Strong leadership attributes or experience – ideal but not essential
  • Strong presentation, communication and influencing skills

 

Job reference:

J-008

 

Indo Professionals is a staffing specialist to the medical device industry. We focus on finding positions within regulatory, quality and clinical research. We work with our job seekers on a project basis, providing one to one consultation and up to the minute market information. Please contact the team today.