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Regulatory Affairs Specialist
1 month ago
About the Role
As a Regulatory Affairs Specialist, you will play a crucial part in maintaining product and site regulatory & quality compliance to ensure license/registration is maintained once granted. This role reports to the Chief Regulatory Affairs and Quality Officer and oversees end-to-end regulatory packages under ODM-Distributor schemes, ensuring compliance with established quality management systems.
Main Responsibilities:
- Preparing Regulatory Documentation: Coordinate and execute 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 necessary.
- Advising on Regulatory Requirements: Advise staff and project team members on data and information required for successful license applications, ensuring their contributions are produced to an appropriate standard for submission.
- Quality Assurance Release: Ensure Quality Assurance release of incoming goods, intermediate, and final product obligations for AliveDx Suisse SA.
- Point of Contact: Be a point of contact for regulatory & quality compliance issues.
- Reporting Incidents: Interface with Competent Authorities for reporting incidents and field safety actions, including FSCA, FSN, recalls, and MDRs (medical device reporting).
- Supporting QMS Organization: Support QMS organization during regulatory inspections or certifications audits.
- Compliance with Company Standards: Conduct all duties in compliance with company Quality Management System and cGMP, GCP, and ISO13485 requirements.
Requirements:
- Masters degree or equivalent in life sciences and 3-5 years of experience in a regulatory/quality role.
- Experience in medical device / IVD / biotech industry.
- Significant specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical devices, or Biologics.
About You
We are seeking a highly experienced Regulatory Affairs Specialist to join our team at Cpl Healthcare. The ideal candidate will have a strong understanding of regulations applicable to medical devices and a proven track record of ensuring compliance with established quality management systems.
Salary: Up to £50,000 + Benefits
