Regulatory Affairs Manager - South UK - Home flexibility - Hampshire

Circa £60,000 per annum plus benefits - Regulatory Affairs - Devices - Regulatory Affairs
Ref: 10 Date Posted: Thursday 12 Sep 2019
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Regulatory Affairs Manager – Medical Devices

North Hampshire with 2-3 days home working

Circa £60,000 per annum

 

Our client is an international medical device company with an established range of leading Class II/III products sold globally.

 

They have a business plan for significant growth and an investment in their RA/QA Team within which they have created a new position for a RA / Regulatory Affairs Manager responsible for assisting in building a regulatory team focused on global product registrations.

 

This position is based in North Hampshire within easy reach of M3 and offers 2/3 days home working.

 

Our client is dedicated to building a robust team of regulatory affairs and quality assurance professionals, offering flexibility, training and career progression – if you are a Regulatory Affairs Manager looking for a new challenge or you are a RA Specialist looking for the next step in your career, please apply today.

 

Job reference:

J-0080

 

Job title:

Regulatory Affairs Manager

 

Salary:

Up to circa £60,000 per annum plus bonus, pension, healthcare

 

Location:

North Hampshire – near M3. Ideal for someone residing in or near Hampshire, Berkshire, Surrey, Oxfordshire, Wiltshire, M4, parts of Home Counties and London

 

Job role:

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

 

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

 

Ideal applicant:

The idea applicant will have proven experience within a medical device registrations role to a RA Specialist or RA Manager. Further key skills sought include;

  • Degree level education – ideally, or equivalent work experience
  • 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
  • Experience of regulatory submissions in multiple countries
  • Strong presentation, communication and influencing skills

 

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.