Regulatory Affairs Specialist
5 days ago
Job Type: 12-month fixed term contract
Location: Outskirts of Edinburgh (Hybrid)
Remuneration: £35,000 - £40,000
We are seeking a highly skilled Senior Regulatory Compliance Officer to join our growing IVD manufacturer and support our Regulatory Affairs Department. In this role, you will be responsible for delivering end-to-end regulatory packages under the ODM-Distributor scheme in compliance with our established quality management system.
The successful candidate will oversee the initial compilation of design control evidences, supplier management, incoming inspection and product release process, product submission, post-market surveillance, vigilance, and associated reporting. You will also be 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 certifications audits.
- Conduct all duties in compliance with company Quality Management System and cGMP, GCP and ISO13485 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
- Experienced in meeting with, making presentations to, and negotiating with regulators.
- 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..).
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