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

The Senior Regulatory Officer is responsible to deliver end to end regulatory package under ODM-Distributor scheme in compliance with an established quality management system, overseeing initial compilation of design control evidences, supplier management, incoming inspection and product release process, product submission, post-market surveillance, vigilance and associated reporting

The Role:

• Preparing and compiling regulatory documentation, coordinating and executing regulatory submission in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Medical Device Approvals (510(k)), and other country requirements as appropriate.
• Advising staff and project team members on data and information required for successful license applications and coordinating their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.
• Ensure Quality Assurance release of incoming goods, intermediate and final product obligations.
• Ensure Supplier management obligations
• Ensure Post-market surveillance obligations
• Ensure Vigilance reporting obligations for
• Be a point of contact for regulatory & quality compliance issues.
• Interface with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting).
• Evaluate Product/Processes Non-Conformances, determine whether their need to be reported to the Competent Authorities.
• Support QMS organisation during regulatory inspections or certifications audits.
• Perform any other duties as reasonably requested from the Company from time to time.
• Conduct all duties in compliance with company Quality Management System and cGMP, GCP and ISO13485 requirements.

Requirements:

• Scientific degree
• Extensive regulatory experience within Medical Devices / IVD
• Experience of working within an FDA licensed manufacturing facility.
• Specialist knowledge of regulations as applied to medical devices, in vitro diagnostic medical devices, or Biologics (93/42/EC, 98/79/EC directives, 510(k), PMA, BLA, CMDR, etc.)
• Significant specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical devices, or Biologics

Benefits:

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

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