Job Description

Title:

Quality & Regulatory Officer

Reports to:

QA&RA Specialist, matrix to Head QA&RA

Location:

Clevedon, Kenn Road BS21 6TH

Hours of Work:

6-month fixed-term contract (37.5 hours per week, Monday to Friday) - Flexible working option; work from home for up to 2 days per week

Direct Reports:

N/A

Scope

This role covers manufacturing, distribution, and commercial activities for Fannin (UK) Ltd (Clevedon & Stroud), including supplier oversight, product/process validation, audit management, complaint handling for both OEM and site, documentation control, and regulatory support activities for UK, EU and other global markets.

Key Relationships

Internal and external quality teams, regulatory authorities/bodies, management, colleagues, suppliers, distributors, and third-party consultants.

Key Accountabilities

Quality (Approx. 80%)

Maintain and ensure compliance with the Quality Management System (QMS) in accordance with ISO 13485, ISO 9001, GMP, and applicable regulatory requirements (MDR, FDA 21 CFR Part 820, etc.). Independently manage day-to-day quality activities, including:

Validation

- drafting, reviewing, and approving protocols and reports for equipment, processes, and software; ensuring activities meet regulatory and internal requirements.

Audit Management

- planning and supporting internal audits; coordinating and supporting external (Notified Body, supplier, customer) audits; tracking and closing audit findings.

Complaint Handling

- investigating product complaints, documenting findings, performing root cause analysis, implementing corrective and preventive actions (CAPA).

Documentation Control

- creating, reviewing, and maintaining controlled quality documents, SOPs, forms, and registers within the eQMS. Support supplier management activities, including risk reviews, performance monitoring, audit scheduling and execution. Conduct quality oversight in production, including non-conformance management, final batch release, and support for environmental monitoring or bioburden control as applicable. Provide QMS training and guidance to internal stakeholders to promote compliance and best practices.

Regulatory (Approx. 20%)

Support maintenance of Technical Documentation and other regulatory files in compliance with MDR, UK MDR 2002, and other market-specific requirements. Assist with impact assessments for regulatory changes and implementation of new or revised requirements. Support preparation and submission of regulatory applications, registrations, and renewals. Contribute to post-market surveillance activities, including vigilance reviews, literature searches, and trend analysis. Assist with regulatory review and approval of labelling, artwork, and promotional materials.

Planning & Execution

Contribute to planning and execution of quality and regulatory activities in alignment with company strategy. Identify and propose improvements to systems and processes to drive efficiency and compliance.

Professional Conduct

Maintain good professional working relationships internally and externally. Promote the company's values and act as an ambassador for Quality & Regulatory compliance.

Qualifications & Experience

Degree in a life sciences, engineering, or related discipline (or equivalent experience).

2-3 years' experience

in a Quality role within the medical devices or regulated healthcare sector. Experience in validation, audit management, complaint handling, and documentation control is essential. Basic understanding of medical device regulatory requirements and standards.

Key Skills & Competencies

Strong knowledge of ISO 13485 and GMP principles. Ability to work independently on quality-related tasks while collaborating effectively on regulatory matters. Skilled in root cause analysis, problem-solving, and CAPA management. Excellent attention to detail with strong organisational and time management skills. Clear, confident communicator with strong verbal and written communication skills. Proficient in Microsoft Office Suite and comfortable with electronic quality systems. Ability to manage multiple priorities in a fast-paced, compliance-driven environment. Positive, solutions-focused mindset with the ability to influence and support colleagues. Data driven decision making approach

Additional Information

Please note: The above describes the requirements of the role as stated in your contract of employment. You may be required to carry out other reasonable duties at the company's request from time to time.

All Fannin UK staff work within quality management systems, and all the above will apply to the product portfolio.

Fannin UK is an Equal Opportunities Employer.

Job Types: Full-time, Fixed term contract
Contract length: 6 months

Pay: 33,000.00-35,000.00 per year

Benefits:

Company pension Work from home
Work Location: Hybrid remote in Clevedon BS21 6TH