Senior Regulatory Compliance Officer
1 month ago
Job Title: Senior Regulatory Compliance Officer
Job Type: 12 month fixed term contract
Location: Outskirts of Edinburgh (Hybrid)
Remuneration: £35,000 - £40,000
Job Summary:
We are seeking a highly skilled Senior Regulatory Compliance Officer to join our growing Regulatory Affairs Department. As a key member of the team, you will be responsible for delivering end-to-end regulatory packages under the ODM-Distributor scheme in compliance with established quality management systems.
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, vigilance, and associated reporting.
- Regulatory Affairs: Advise staff and project team members on data and information required for successful license applications, coordinating their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.
- Regulatory Support: Interface with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting).
- Regulatory Compliance: Evaluate Product/Processes Non-Conformances, determine whether they need to be reported to the Competent Authorities.
- Regulatory Audits: Support QMS organization during regulatory inspections or certifications audits.
Requirements:
- Education: Master's degree or equivalent in life sciences and 3/5 years of experience in a regulatory/quality role.
- Industry Experience: Experience in the medical device / IVD / biotech industry.
- Regulatory Knowledge: Significant specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical devices, or Biologics (93/42/EC, 98/79/EC directives, 510(k), PMA, CMDR, etc.).
- Vigilance Processes: Specialist knowledge of vigilance processes for US, EU and other jurisdictions as appropriate (MDR, MEDDEV 2.12, etc.).
What We Offer:
We offer a competitive salary, a dynamic work environment, and opportunities for professional growth and development. If you are a motivated and experienced regulatory professional looking for a new challenge, please submit your application.
Contact Information:
For more information, please reach out to lucy.kirkaldy@cpl.com. Please note that you MUST have the full right to work in the UK and be able to be office-based 3x a week.
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