Implants International Ltd
Regulatory Affairs Specialist
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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.
Key Requirements:
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- Regulatory Experience: 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).
- Document Management: Strong skills in preparing and managing Regulatory Documentation and Regulatory Submissions, including maintaining product technical files, design dossiers, and product registration materials.
- Regulatory Knowledge: 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.
- Quality Assurance: Experience in quality assurance and compliance (ideally within a medical device environment) including participation in audits, CAPA, risk management, and post-market surveillance.
- Communication Skills: Excellent written and verbal communication skills, with the ability to interpret complex regulations and clearly document findings and decisions.
- Organizational Skills: Strong attention to detail, organizational skills, and the ability to manage multiple projects and deadlines in a regulated environment.
- Team Collaboration: Comfort working on-site in a cross-functional team, with a proactive, solutions-oriented, and ethical approach to regulatory and quality challenges.
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Job Details:
- Hours of Work: 37.5 hours per week, Monday to Friday
- Holidays: 30 days (incl. statutory) rising to 33 days in the 4th year
- Benefits: Free car parking on-site
- Job Types: Full-time, Permanent
- Pay: £45,000.00 per year with a review after 6 months
Work Location:
- In person
Note:
REGRETFULLY, WE ARE UNABLE TO SPONSOR ANY CANDIDATES WITH WORK VISAS
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