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Regulatory Affairs Engineer

Location: Crawley, West Sussex Salary: £50000 - £55000 per annum
Sector: Medical Devices Specialism:
Type: Permanent Contact: Matt Henocq

The Company

My client offers a global environment where entrepreneurial thinking is highly valued. You will be a part of a motivated and self-propelled team where you have the ability to influence the development of the company as well as your own career. Regulatory Affairs is the decision authority on regulatory, environmental and export control matters across the organization. The function proposes and implements company policy on regulatory issues such as: export control, trade compliance, labelling review, product registrations, standardization, regulatory strategy, radiation safety etc.


The role:

The Regulatory Affairs team is now looking for a Regulatory Affairs Engineer. The Regulatory Affairs Engineer works as part of the European team to support my client globally in the delivery of its products in a regulated environment. You will work closely with business areas including manufacturing and supply chain, research and development and engineering. You will liaison with regulatory authorities. This is a high impact role that works in a fast-paced dynamic environment and makes a meaningful contribution to Elekta's business. The position is placed in Crawley.

Responsibilities:

  • Provide guidance on product regulation and translate into meaningful business requirements
  • Gain market access for our regulated products including submissions
  • Communicate with regional and business teams and prepare responses on all governing agency actions
  • Review promotional labelling
  • Represent regulatory affairs in new product development as well as maintenance projects
  • Participate in product release process
  • Participate in regulatory process improvements work


Qualifications and experience:

To be successful in this role we would prefer solid experience in Regulatory Affairs. You have gained experienced at an industrial company working with manufacturing or product development, preferably in the MedTech or Pharma industry.

We value experience from working with quality assurance, compliance issues and experience from working with internal and external audits. We also value your ability to apply your expertise to a variety of problems and being able to find smart solutions within the regulatory and quality area. Your English skills are excellent, both orally and written. You have a Master of Science degree (Mechanical, Electrical, Industrial Engineering, etc.) or equivalent engineering degree. We are looking for a regulatory affairs professional, preferably with experience in particular product submissions strategies and handling, or equivalent.

This advert was posted by Gold Group - one of the UK's leading niche recruitment consultancies. We span a variety of specialist industries and are the recruitment company to help you find your next career opportunity. We pride ourselves on our commitment to candidates and stick to our ethos of finding the right role for the right person. Visit our website or get in touch today to discuss this role, find out what else we've got or just for a chat about the state of your industry. Services advertised by Gold Group are those of an Agency and/or an Employment Business. Please be aware that we receive a high volume of applications for every role advertised and regularly receive applications from candidates who exceed the job credentials. We will only contact you within the next 14 days if you are selected for interview. A copy of our privacy policy can be found here: https://www.goldgroup.co.uk/about-us/privacy-policy. Gold Group is an equal opportunity & diversity employer. A copy of our equal opportunity & diversity policy can be found here: https://www.goldgroup.co.uk/about-us/equality-and-diversity-policy

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