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Regulatory Engineer

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    Will Godfrey

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    14 days ago


A fantastic permanent opportunity for a Regulatory Engineer with strong Medical Devices experience to join a well established Med Tech company based in Buckinghamshire who design, manufacture and distribute Class I, IIa and IIb products globally!

Due to continued growth and ever increasing global regulatory requirements they are looking to expand the Regulatory Team of 5 as they continue to meet the requirements of ISO 13485, EC 93/42 and the EU MDR in addition to the regulatory requirements of the individual markets in which the company operates.


  • Work with internal departments and external regulators, suppliers and customers with a broad remit to ensure the ongoing product and systems compliance to the applicable regulations and standards.
  • Assist in the maintenance and review of technical product files and assist in the continue transfer to the MDR.
  • Work with the design department to ensure ongoing regulatory compliance of current and new products.
  • Collaborate with a team of design engineers to produce a variety of technical documentation (such as essential requirements, risk assessments, test reports, etc).
  • Produce documentation in compliance with the relevant regulatory standards.
  • Work with internal departments, Competent Authorities, other national authorities and the Notified Body on product and company registrations.
  • Work in conjunction with the Sales department to provide the necessary documentation to support the registration of products in international territories.
  • Author, proofread, liaise with translators and publish user manuals for a variety of products.
  • Assist in the actioning of regulatory requirements associated with NCRs, customer complaints, CAPA reports etc.


  • Experience with MDD/MDR is essential.
  • Experience of interpreting and implementing standards and regulations essential.
  • Broad background in regulatory compliance of systems and products within a QMS essential.
  • Broad background in electro/mechanical products highly desirable, along with an understanding of the impact of regulatory requirements.
  • Experience of medical standards and European/FDA regulations highly desirable.
  • Experience of medical device manufacturing and medical standards highly desirable.
  • Familiarity with translation/localisation processes would be useful.

For immediate consideration please forward your most up to date CV

Austin Fraser is acting as an Employment Agency in relation to this vacancy.

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.