Regulatory Affairs Office + Senior

Here at SRG, we are proud to be supporting this established IVD company on their search for two regulatory affairs professionals.

Regulatory Affairs Officer

The role is responsible for building regulatory strategy, determining applicable regulatory requirements, proposing solutions to comply with regulatory requirements and managing product license registration with the appropriate regulatory authorities worldwide.

It is also responsible to build, implement and maintain regulatory compliance processes including, regulatory evaluation of changes and non-conformances, post-market surveillance, vigilance and associated reporting, regulatory and standard watch. Furthermore, the role is responsible for providing guidance to the company on regulatory requirements and aspects.

• Prepare and compile regulatory documentation, coordinate, and execute regulatory submission with:

• FDA
• European Notified Bodies
• Health Canada
• Any other territories as appropriate

in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Biologics License Applications (BLA), Medical Device Approvals (510(k)), Canadian Medical Device Regulations (CMDR) - Part 1 and other country requirements as appropriate.

• Liaise with regulatory authorities and external contract bodies and, in response to requests from these, collate and interpret specialised information.
• Ensure maintenance of product regulatory documents and technical files to ensure ongoing compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 CFRs, BLA, 510(k), CMDR - Part 1 requirements and other non-registered product requirements to support compliance.
• Advise the company's staff and project team members on data and information required for successful license applications and co-ordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.

• Develop product labelling regulatory requirements for the company's products and for customer contracted products including but not limited to package labels, product labels and instructions for use.

• Ensure post-market surveillance obligations are met and maintain the post-market surveillance process.
• Lead and coordinate the vigilance process in interface with the complaint handling process.
• Ensure Vigilance reporting obligations, i.e. interface with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting), BPDR (Biological Products Deviation Reports).
• Evaluate Product/Processes Non-Conformances, determine whether they need to be reported to the Competent Authorities
• Contribute to the regulatory watch process by maintaining knowledge of new or updated regulatory requirements, guidance documents and industry standards.

Senior Regulatory Affairs Officer

The role 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. Furthermore, the role is responsible for providing guidance to the company on regulatory requirements and aspects.

The role will provide support to the Head of Pre-Market Regulatory Affairs with regard to planning and co-ordination of activities and with regard to training and supervision of other members of the Regulatory Affairs team and to ensure continuous development of junior staff to develop their capabilities.

• Prepare and compile regulatory documentation, coordinate and execute regulatory submission with:

• FDA
• European Notified Bodies
• Health Canada
• Any other territories as appropriate

in compliance with ISO13485, IVD Directive 98/79/EC, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Canadian Medical Device Regulations (CMDR) - Part 1 and other country requirements as appropriate.

• Review analytical data from development studies and performance evaluation studies to ensure regulatory requirements are met.
• Advise Quotient staff and project team members on data and information required for successful license applications and co-ordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.
• Develop product labelling regulatory requirements for Quotient 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 with ISO13485, IVD Directive 98/79/EC, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs) Biologics License Applications (BLA), Medical Device Approvals (510(k), Canadian Medical Device Regulations (CMDR) - Part 1 and other non-registered product requirements to support compliance for Quotient and its products.
• Liaise with regulatory authorities and external contract bodies and, in response to requests from these, to collate and interpret specialised information.
• Actively participate in product development projects on a regular basis in order to provide guidance on regulatory requirements and to provide supporting regulatory documentation.
• Ensure that changes are documented in accordance with quality system requirements and are communicated in a timely basis as appropriate to the Regulatory Authorities.
• Assist with the implementation of the Company's Quality Policy to ensure compliance with Good Manufacturing Practice (cGMP), 13485 standards the 98/79/EC IVD Directive, IVD 2017/746 Regulation, FDA Regulations, Health Canada Medical Device Regulation, Part 1, Good Clinical Practice (GCP) and approved Health and Safety Policies.

As the ideal candidate for these roles, you will have relevant experience working with regulatory affairs for the IVD/Medical Device market. Knowledge and practical experience of CE (IVDR) and FDA regulations, including the preparation of PMA, BLA and/or 510k submissions is desirable.

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