Position of Regulatory Affairs
About the job
Company Description Implants International Ltd. is a bio-engineering company focused on arthroplasty, trauma, and spinal implant solutions. The company designs and manufactures all products on site, ensuring close control over quality and innovation. Its manufacturing plant holds ISO, FDA, and CE certifications, reflecting strong adherence to global regulatory and quality standards. Team members work in an environment committed to technical excellence, patient safety, and continuous improvement. More information about the company, its products, and its values is available on the Implants International Ltd. website.
Role Description The Regulatory Affairs Specialist is a full-time, on-site role based in Stockton-On-Tees. This role is responsible for preparing, reviewing, and maintaining regulatory documentation to support product registrations, approvals, and ongoing compliance.
- Demonstrated experience with regulatory frameworks for medical devices, including Regulatory Affairs and Regulatory Compliance across relevant markets (e.g., UK, EU, USA and other international regions as applicable).
- Strong skills in preparing and managing Regulatory Documentation and Regulatory Submissions, including maintaining product technical files, design dossiers, and product registration materials.
- Thorough understanding of Regulatory Requirements for medical devices (e.g., MDR, UKCA, ISO 13485 and FDA) Must have hands-on experience of Class IIb & Class III medical devices
- Experience in quality assurance and compliance (ideally within a medical device environment) including participation in audits, CAPA, risk management, and post-market surveillance.
- Excellent written and verbal communication skills, with the ability to interpret complex regulations and clearly document findings and decisions.
- Strong attention to detail, organizational skills, and the ability to manage multiple projects and deadlines in a regulated environment.
- Comfort working on-site in a cross-functional team, with a proactive, solutions-oriented, and ethical approach to regulatory and quality challenges.
Hours of work: 37.5 hours per week Monday to Friday
Holidays: 30 days (incl stats) rising to 33 days in the 4th year
Free car parking on-site
References essential
Job Types: Full-time, Permanent
Pay: £35,000 to £45,000.00 per year depending on relevant experience.
Work Location: In person
- REGRETFULLY, WE ARE UNABLE TO SPONSOR ANY CANDIDATES WITH WORK VISAS
Pay: £35,000.00-£45,000.00 per year
Benefits:
- Free parking
- On-site parking
Work Location: In person
