Title:
Quality & Regulatory Officer -12 month Fixed Term Contract (maternity cover)
Reporting to:
Nischith Raphael (Head of Quality & Regulatory)
Location:
Fannin (UK) Ltd (Kenn Road, Clevedon) - 3 days required in the office, 2 days can be worked from home
Scope:
Manufacturing and distribution activities for Fannin (UK) Ltd (Clevedon) incl distribution via Measham, New Product Development & International.
Key Relationships:
Quality groups (internal & external), Regulatory Authorities/Bodies, Management, Colleagues, suppliers and third-party consultants.
Key Accountabilities:
* Maintain & ensure compliance with quality system & regulatory requirements for Medical Device Regulations, including the 3rd party OEM manufacturing processes supplied to Fannin (UK) Ltd.
* Maintain in-depth knowledge of the business, its products, regulatory requirements, suppliers, customers, and the market dynamics.
* Maintain & implement local & group company policies and procedures.
* Maintain good professional working relationships both internally and externally.
Planning:
Conduct planning (both long and short term) for the Quality department, in line with the company’s defined strategy within scope of responsibilities.
Ensure compliance to current relevant regulations & standards as well as assessing the potential impact of new/updated regulations.
Execution:
Quality Management:
* Management of the Fannin (UK) Ltd (Clevedon) Quality Management System: Compliance with relevant GMP, Quality systems and ethical standards such as, the Medical Device Directive/Regulations (MDD/MDR), FDA CFR 21 Part 820, TGR 2002 Sch 3, Part 4, SOR /98-282 and ISO13485/9001.
* Liaise with Notified Body/Competent Authorities for the management of (re)certification & surveillance audits.
* Vigilance including investigation of complaints, FSCA/FSN, non-conformities and completing corrective & preventative actions Implementation and management of eQMS.
* Quality activities to be undertaken within production areas, including complaints, non-conformances investigations, and bioburden schedule management, production improvement projects and final batch release.
Confidential:
* Complete risk reviews following changes and non-conformities etc. to ensure they remain current to all identified risks. Update risk management files accordingly.
* Management and maintenance of risk file.
* Oversight and support to distribution activities – ensuring devices are registered, with the territory product authorisation lists current & accurate for each territory.
* Undertake an active role in internal and external audits (including notified body, supplier & distributor).
* Management of suppliers & completion of supplier risk reviews in order to identify further actions (e.g. supplier audit requirements).
* Providing effective communication of the internal QMS and providing training & support to internal stakeholders.
* Support in planning and executing Notified Body audits.
* GAP analysis for new releases of standards applicable to Fannin UK.
Regulatory:
* Management of the Fannin (UK) Ltd (Clevedon) Technical Files, including: Preparation of Medical device files, including product specifications, risk assessments, validations, technical drawings, labels, and instructions for use to ensure compliance to the relevant Medical Device Regulations or other territory requirements.
* Compilation & review of clinical evaluations, along with the management of a post market clinical follow–up plan, to ensure real time updates to risk assessments and clinical data.
* Execution of post-market surveillance, incl. vigilance review, performing literature & news searches to identify and monitor any potential safety issues and innovations of the products within the marketplace.
* Preparation and maintenance of Design History File, Design Master Record Support with Authorised Representative role for Fannin UK.
* Providing support of Regulatory & Registration requirements for UK, EU & ROW: Product and economic operator registrations.
* Preparation & timely submission of regulatory applications, as required (including CE technical file, Health Canada applications and 510K).
* Support and respond to distributors/customers following regulatory enquiries & documentation requests.
* Review of labelling/artwork updates submitted to Fannin (UK) Ltd from approved suppliers/sub-contractors.
* Providing support for the New Product Development Group in Medical Devices.
* Review and approval of technical documentation for supplier(s) and/or products.
* Compilation and management of technical file documentation to ensure compliance to the relevant Medical Device Regulations or other territory requirements.
* Maintenance of the Regulatory Intelligence activities for Fannin (UK) Ltd, and completion of standard gap analysis, where necessary.
Other:
* Approved signatory for and management of: Release of sterile product.
* Risk assessments and General Safety & Performance Requirements.
* Compilation and approval of validation protocols & reports, including laboratory/bench testing.
* Review and approval of artwork, labelling and promotional literature.
* Management, compilation, review & sign off for SOPs/Forms/Registers.
* Regulatory submissions and relevant documents (as required – i.e., declaration of foreign sale or Certificate of free sale etc.).
* Vigilance documents for submission.
* Ethical/Regulatory reviewer of new suppliers, products and distributors.
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