Regulatory Affairs Specialist
14 hours ago
Job Title: Quality & Regulatory Affairs Specialist
Job Type: Permanent position
Location: Outskirts of Edinburgh (Hybrid, 3x a week in the office)
Remuneration: Up to £50,000 + Benefits
Cpl Life Sciences is seeking a highly skilled Quality & Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs Department, you will be responsible for delivering end-to-end regulatory packages under ODM-Distributor schemes in compliance with established quality management systems.
Key Responsibilities:
- Preparing and compiling 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.
- 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.
- Ensuring Quality Assurance release of incoming goods, intermediate, and final product obligations for Cpl Life Sciences.
- Ensuring Post-market surveillance obligations.
- Ensuring Vigilance reporting obligations.
- Being a point of contact for regulatory & quality compliance issues.
- Interfacing with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting).
- Evaluating Product/Processes Non-Conformances, determining whether they need to be reported to the Competent Authorities.
- Supporting QMS organization during regulatory inspections or certifications audits.
- Performing any other duties as reasonably requested from the Company from time to time.
- Conducting 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
- 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.).
- Specialist knowledge of vigilance processes for US, EU, and other jurisdictions as appropriate (MDR, MEDDEV 2.12, etc.)
For more information, please contact us.
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