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Regulatory Affairs Engineer

Location: Crawley, West Sussex, England Salary: £60000 - £65000 per annum
Sector: Medical Devices Type: Permanent
Contact: Matt Henocq Job Published: 9 days ago

Regulatory Affairs Engineer

Description -

The Regulatory Affairs Engineer works as part of the European team to support the organisation 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 the business.

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 labeling
  • Represent regulatory affairs in new product development as well as maintenance projects
  • Participate in product release process
  • Participate in regulatory process improvements work

Relevant Knowledge, skills and competencies -

  • 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 or equivalent.
  • We are looking for a regulatory affairs professional, preferably with experience in particular product submissions strategies and handling, or equivalent.

Highly valued personal qualifications and competencies are as following:

  • Excellent communication skills
  • Ability to work unsupervised under own initiative
  • Ability to interpret authority regulations
  • Ability to mentor and lead problem solving
  • Appreciate compliance work
  • Appreciate the role as specialist
  • Flexible
  • Analytical
  • Excellent problem solving skills

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
We will contact you within the next 14 days if you are selected for interview. For a copy of our privacy policy please visit our website.

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