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Regulatory Affairs Specialist
2 months ago
Job Type: Contract
Location: Edinburgh
Remuneration: £35,000 – £40,000
An exciting opportunity has arisen to join a leading IVD manufacturer and support a growing Regulatory Affairs Department. In this role, you will be responsible for delivering an end-to-end regulatory package under ODM-Distributor scheme in compliance with established quality management system, overseeing (but not limited to) 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 is responsible for maintaining product and site regulatory & quality compliance to maintain license/registration once granted.
Key Responsibilities:- 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.
- 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).
- Support QMS organization during regulatory inspections or certification audits.
- Conduct all duties in compliance with company Quality Management System and cGMP, GCP and ISO13485 requirements.
- Master degree or equivalent in life sciences and 3-5 years of experience in a regulatory/quality role.
- Experience in 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.).
