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Regulatory Affairs Officer

SRG
Posted 6 days ago, valid for 20 days
Location

Edinburgh, City of Edinburgh EH13EG, Scotland

Salary

£60,000 - £72,000 per annum

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Contract type

Full Time

Life Insurance

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Sonic Summary

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  • The position of Regulatory Affairs (RA) Officer is available in the Edinburgh area, offering hybrid working and is a full-time, permanent role with a 37.5-hour workweek.
  • Candidates should have a scientific degree and at least 2-3 years of regulatory experience, preferably in Medical Devices or IVD, although pharmaceutical experience will be considered.
  • The role involves preparing regulatory documentation, managing product license registrations, and developing product labeling requirements for various international markets.
  • The salary for this position is competitive, reflecting the candidate's experience and expertise in regulatory affairs.
  • Benefits include private medical cover, life assurance, additional annual leave, an annual bonus scheme, and a cycle-to-work scheme, among others.

Regulatory Affairs (RA) Officer

Location: Edinburgh area - hybrid working

Type: Full-time, Permanent, 37.5 hours per week.

SRG is working with a leading Biotechnology company based in the Edinburgh area who are looking for a Regulatory Affairs officer to join their team on a permanent basis.

The regulatory affairs officer is responsible for building regulatory strategy, determine applicable regulatory requirements, propose solutions to comply with regulatory requirements and manage product license registration with the appropriate regulatory authorities worldwide.

The Role:

  • Prepare and compile regulatory documentation, coordinate and execute regulatory submission for countries including US, EU, Canada and any other territories as appropriate in compliance with relevant regulations.
  • Develop product labelling regulatory requirements for products and for customer contracted products including but not limited to package labels, product labels and instructions for use.
  • Liaise with internal and external parties as required to support development of product labelling.
  • Contribute to the regulatory watch process by maintaining knowledge of new or update regulatory requirements, guidance documents and industry standards.
  • Ensure maintenance of product regulatory documents and technical files (including US, EU, Japan, Brazil, Canada) to ensure ongoing compliance.
  • Liaise with regulatory authorities and external contract bodies and, in response to requests from these, to collate and interpret specialised information.
  • Assist with the implementation of the Company's Quality Policy.
  • Contribute to the design and implementation of regulatory processes and identify areas for potential improvement.

Requirements:

  • Scientific degree
  • Previous regulatory experience within Medical Devices / IVD is preferred but pharmaceutical regulatory experience will be considered.
  • Experience of working within an FDA licensed manufacturing facility.
  • Experience in meeting with and negotiating with regulators.

Benefits:

  • Private Medical cover
  • Life assurance
  • Additional annual leave
  • Annual bonus scheme
  • Cycle to work scheme + more.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.

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