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Regulatory Compliance Officer

2 months ago

Greater Edinburgh, United Kingdom Cpl Life Sciences Full time
About the Role

We are seeking a highly skilled Regulatory Compliance Officer to join our growing Regulatory Affairs Department at Cpl Life Sciences. As a key member of our team, you will be responsible for delivering end-to-end regulatory packages under the ODM-Distributor scheme in compliance with our established quality management system.

Key Responsibilities
  • Regulatory Documentation: Prepare and compile regulatory documentation, coordinating and executing regulatory submissions 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.
  • Regulatory Compliance: Ensure Quality Assurance release of incoming goods, intermediate, and final product obligations, as well as supplier management, post-market surveillance, and vigilance reporting obligations.
  • Regulatory Affairs: Advise staff and project team members on data and information required for successful license applications, and coordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.
  • Regulatory Inspections: Support our Quality Management System organization during regulatory inspections or certifications audits.
  • Regulatory Reporting: Evaluate Product/Processes Non-Conformances, determine whether they need to be reported to the Competent Authorities, and interface with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting).
Requirements
  • Education: Master's degree or equivalent in life sciences.
  • Experience: 3-5 years of experience in a regulatory/quality role, preferably in the medical device / IVD / biotech industry.
  • Skills: Significant specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical devices, or Biologics, as well as specialist knowledge of vigilance processes for US, EU, and other jurisdictions as appropriate.
About Us

Cpl Life Sciences is a leading provider of life sciences recruitment solutions. We are committed to delivering exceptional service to our clients and candidates, and we are seeking a highly skilled Regulatory Compliance Officer to join our team.