Reference Number: JO-2410-542350
Quality & Regulatory Affairs Specialist
Rate: Negotiable
Job Type: Permanent
Location: Edinburgh
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
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 & Regulatory Affairs Specialist is responsible for delivering end-to-end regulatory packages under ODM-Distributor schemes in compliance with established quality management systems, overseeing (but not limited to) initial compilation of design control evidences, supplier management, incoming inspection and product release processes, 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. The role is also responsible for supporting other regulatory and quality affairs team members as needed, including training and guidance as appropriate.
Responsibilities:
1. 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.
2. 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.
3. Ensuring Quality Assurance release of incoming goods, intermediate, and final product obligations for AliveDx Suisse SA.
4. Ensuring post-market surveillance obligations.
5. Ensuring vigilance reporting obligations.
6. Being a point of contact for regulatory & quality compliance issues.
7. Interfacing with Competent Authorities for reporting incidents and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting).
8. Evaluating Product/Processes Non-Conformances, determining whether they need to be reported to the Competent Authorities.
9. Supporting QMS organization during regulatory inspections or certifications audits.
10. Performing any other duties as reasonably requested from the Company from time to time.
11. Conducting all duties in compliance with company Quality Management System and cGMP, GCP, and ISO13485 requirements.
Requirements:
1. Master's degree or equivalent in life sciences and 3/5 years of experience in a regulatory/quality role.
2. Experience in the medical device/IVD/biotech industry.
3. Experienced in meeting with, making presentations to, and negotiating with regulators.
4. Specific technical competencies required for the role (e.g., GMP, GLP exposure, FDA exposure, IT packages, technical writing skills).
5. 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.).
6. Specialist knowledge of vigilance processes for US, EU, and other jurisdictions as appropriate (MDR, MEDDEV 2.12, etc.).
For more information, please reach out to lucy.kirkaldy@cpl.com. Please note that you MUST have the full right to work in the UK and be able to be office-based 3x a week.
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