Vacancy: United Kingdom

RA Officer

The purpose of the role is to write or support the writing of detailed, well-reasoned and complete submissions to major Regulatory Agencies around the world in support of Endomag’s products. This will involve liaison with all members of the Endomag team which may include QA, R&D, Product Engineering, Operations and Marketing.

Vacancy

Role

This is a good opportunity for a person with up to 5 years into their regulatory career to be able to develop in the widely divergent, technical and fast moving high technology medical devices industry. It is also an opportunity to become familiar with the approach of multiple regulatory jurisdictions.

Responsibilities

  • Familiarisation with the Endomag products and technology and keeping an up to date knowledge of developments.
  • Gathering relevant information about Endomag products for the purpose of writing complete documents or parts of documents for the purpose of regulatory submission.
  • Familiarisation with available guidance documents from regulatory jurisdictions of interest.
  • Drafting complete documents or parts of documents for internal documentation and regulatory submission.
  • Supporting the Regulatory Director in writing and finalising regulatory submissions.
  • Support the Regulatory Director in interactions with Regulatory and Notified Bodies.

Qualifications

  • Degree or equivalent in biology/biochemistry/biotechnology/Medical technology or closely related field.

Experience and knowledge

  • Familiarity with medical device or pharmaceutical regulatory framework within the EU/USA.
  • Familiarity with Quality Management systems in Medical Device or pharmaceutical industries.
  • Experience of technical writing within medical device or pharmaceutical industries.
  • Experience of direct interaction with Regulatory and Notified bodies in US/EU.
  • An understanding of Regulatory Science.

Abilities and skills

  • Highly focussed, but able to work on multiple projects concurrently.
  • Excellent scientific/Technical writing skills with critical attention to detail and high levels of accuracy.
  • Ability to quickly grasp the basis of unfamiliar technologies.
  • Ability to put together cogent technical arguments.

How to apply

Applications

To apply for this role, please email:

recruitment@endomag.com

Please attach a cover letter and CV/resume.