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 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.
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