Quality and Regulatory Coordinator

Job Title: QA/RA Coordinator - EMEA

Reporting to: QA/RA Lead UKINORD (and EMEA)

Business Function: QA/RA EMEA

Duration of Employment Contract: 12 Months

Location: Onsite: 73/76 Shrivenham Hundred Business Park, Swindon, SN6 8TY

Company Overview

CONMED is a global leader in medical technology, dedicated to developing and delivering surgical and patient monitoring products that empower physicians to provide superior care, achieving better clinical outcomes for their patients.

Our products, recognized as technological frontrunners in their respective fields, are trusted by healthcare professionals worldwide. We serve key specialties including Orthopaedics, Laparoscopic, Robotic & Open Surgery, Gastroenterology & Pulmonology, and Cardiology & Critical Care, where the CONMED name is synonymous with quality and innovation. With a diverse portfolio designed to meet the specific needs of each specialty, we offer our customers both choice and convenience, enhancing care at every touchpoint.

Job Summary

Supports quality and regulatory practices across EMEA, with a focus on compliance and maintaining documentation, whilst fostering continuous improvement and knowledge sharing across the region.

Key Responsibilities

• Support the ongoing maintenance and verification of product registrations with the MHRA, ensuring data accuracy and the completeness of associated documentation.
• Coordinate the collection and update of information for incomplete or outdated fields in regulatory databases, working cross-functionally to close data gaps.
• Support with new regulations introduced within the UK to ensure compliance.
• Assist in organising and streamlining documentation within the Windchill system for the EMEA QMS, including appropriately linking documents and ensuring correct version control.
• Collaborate on the development of a QMS guide tailored to the International QA/RA team, incorporating both joint SOPs and local procedural documentation. Serve as a liaison between regional and international QA/RA teams to ensure alignment.
• Provide administrative and procedural support in document control activities, including the formatting, updating, and release of controlled documents.
• Upload and release controlled documents in Windchill in accordance with quality standards and document control procedures.
• Ensure regulatory documentation is audit-ready and in compliance with applicable standards.
• Assist with internal and external audit preparation, including document collation, tracking of findings, and follow-up actions.
• Contribute to continuous improvement initiatives by identifying opportunities for enhanced compliance efficiency and documentation practices.
• Contribute to the upskilling of staff across the EMEA region by promoting awareness and understanding of QA/RA processes, regulations, and best practices through training support, knowledge sharing, and ongoing communication.
• Adhere to and uphold all company policies and regulatory standards, including business conduct, corporate ethics, quality system compliance, and regulatory affairs. Proactively familiarise yourself with the specific policies and requirements relevant to your role, ensuring these standards are fully integrated into daily operations and long-term strategic planning. Consult with management or relevant departments as needed to guarantee full compliance with corporate policies and regulatory obligations.

The above description outlines the principle duties of the job role and is not an exhaustive list. The job holder may be asked to perform other tasks and duties commensurate with their skills, experience and position.

Person Specification

Education / Qualifications

Desirable

• A degree in a subject related to quality, regulatory or compliance.

Essential

• Educated to degree level or equivalent, or working towards.
• GSCE and A level qualifications.
• A full, valid UK driving licence.

Experience, Skill, knowledge and attributes

Desirable

• Experience within quality, regulatory or compliance.
• Experience within the medical technology industry.

Essential

• Minimum of 1 year proven administration experience.
• Excellent attention to detail.
• Proficient in all Microsoft Office applications
• Strong communication and presentation skills.
• Results-oriented with a strong drive to achieve and exceed goals.
• Self-driven and a positive mindset.
• Excellent time management and ability to effectively prioritize
• Exercises strong decision-making skills.
• Exceptional focus and ability to bring tasks to completion.
• Derives energy from building relationships and networks.
• Has a strong desire to create value for the customer.
• Enjoys working in a team and sees collaboration as a key success factor.

Job Types: Full-time, Fixed term contract

Contract length: 12 months

Pay: £24,420.00-£26,000.00 per year

Benefits:

• Company events
• Company pension
• Cycle to work scheme
• Employee discount
• Health & wellbeing programme
• Life insurance
• On-site parking
• Private dental insurance
• Private medical insurance
• Referral programme
• Sick pay
• Work from home

Application question(s):

• Do you hold a full Driving Licence?

Experience:

• Administration: 1 year (preferred)

Work Location: In person