Regulatory Affairs Specialist (Senior) - Medical Devices - Edinburgh

£70,000 per annum plus bonus, healthcare, pension - Regulatory Affairs - Devices - Regulatory Affairs
Ref: 17 Date Posted: Thursday 12 Sep 2019
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Regulatory Affairs Specialist / Senior – Medical Devices

Circa £70k

Scotland – near Edinburgh

 

Our client is an established medical device company based near Edinburgh. They are looking to secure the services of a permanent Regulatory Affairs Specialist / Senior RA Specialist.

 

This position reports to the RA Director with responsibilities for 510(k) submissions as well as implementing and maintaining regulatory strategies.

 

In return, our client is offering a highly competitive salary package of up to £70,000 per annum plus an excellent benefits package which includes bonus, pension and healthcare.

 

Our client is a growing medical device specialist with a history spanning over 20 years. This is great time to be joining a financially strong and growing medical device company in a pivotal role.

 

Position;

Snr RA Specialist / Senior Regulatory Affairs Specialist

 

Location;

Scotland – near Edinburgh

 

Salary;

Up to £70,000 per annum plus bonus, healthcare, pension

 

Job reference;

J-0012

 

Applicant requirements;

Our client is looking for a proven, senior level Regulatory Affairs professional with a solid career history within medical devices. Essential to this role is hands-on FDA/510(k) submissions experience. Further experience sought includes;

  • Degree level education – ideally within life sciences, engineering or similar disciplines. Or equivalent work experience
  • Expert knowledge of ISO 13485
  • Regulatory submissions experience
  • Clinical trials experience – ideally
  • Excellent presentation, communication and influencing skills

 

Job role;

The successful Regulatory Affairs Specialist / Senior Specialist will be driving 510(k) submission projects as well as CE marking. You will also be providing regulatory expertise in the development and registration of new products. In addition, this Snr RA Specialist role will be working with CROs and will advise on regulatory strategy providing guidance in the development and validation of existing and new products.

 

Indo Professionals is a specialist staffing company focused on placing regulatory, quality and clinical research professionals within the medical device industry. We work with our job seekers on a one to one basis providing full career consultation and assistance throughout the recruitment process. Please contact us today to discuss your next career challenge within med tech.