Quality Assurance Specialist
3 weeks ago
Job Type: Permanent position
Location: Outskirts of Edinburgh (Hybrid, 3x a week in the office)
An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department. Reporting to the Chief Regulatory Affairs and Quality Officer, the Quality and Compliance Officer is responsible for delivering end-to-end regulatory packages under ODM-Distributor schemes in compliance with established quality management systems.
Key Responsibilities:
- Oversee the initial compilation of design control evidence, supplier management, incoming inspection, and product release processes.
- 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.
- 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.
- Ensure Quality Assurance release of incoming goods, intermediate, and final product obligations for AliveDx Suisse SA.
- Be a point of contact for regulatory and quality compliance issues.
- Interface with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting).
- Support QMS organization during regulatory inspections or certifications audits.
- Conduct all duties in compliance with company Quality Management System and cGMP, GCP, and ISO13485 requirements.
Requirements:
- Master's degree or equivalent in life sciences and 3/5 years of experience in a regulatory/quality role.
- Level required in the function (e.g., validation, finance, quality control).
- Experience in the medical device/IVD/biotech industry.
- Specific technical competencies required for the role (e.g., GMP, GLP exposure, FDA exposure, IT packages, technical writing skills).
- 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.).
Company: Cpl Life Sciences
Language: English
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