Biocomposites is an international medical devices company that engineers, manufactures, and markets world‑leading products for use in infection management in bone and soft tissue. Based in Keele, UK, it operates globally across Europe, USA, Argentina, Canada, China, and India. The products regenerate bone and target infection risks across specialties such as musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle, podiatry, and sports injuries. They are used in more than one million procedures per annum and are sold in over 100 countries.
Job Summary
Development role providing foundational knowledge in regulatory affairs, supporting regulatory activities and building a thorough understanding of medical device regulation.
Reports to
A member of the Regulatory Affairs management team.
Location & Working Pattern
Keele office. Standard working hours (Mon‑Fri, 9.00 – 5.00, 35 hpw).
Duties & Responsibilities
- Prepare and submit documents to maintain the company’s site and product registrations in accordance with country requirements.
- Assess and understand the impact of design changes on regulatory compliance and product registration.
- Utilise information systems to track registration status and renewal dates for products and regulatory documents.
- Maintain awareness and support colleagues regarding regulatory status of products in relevant countries.
- Support the creation of technical documentation to support product registrations.
- Provide general support for activities within the regulatory and compliance teams.
Essential Requirements
- Bachelor’s Degree in a life science or equivalent.
- Organisational skills and an ability to work to tight timelines.
- Exceptional team skills.
- Enthusiastic and eager to learn, motivated to develop a career within Regulatory/Medical Devices.
- Proficient in the use of Microsoft Office.
- Excellent communication skills when liaising within the company and with external customers.
- Commutable to the office and able to work Monday to Friday, 9am‑5pm.
Desirable Requirements
- Medical Devices training or qualification.
- Medical Device experience.
- Knowledge of ISO 13485.
- Knowledge of Medical Devices.
- Understanding of regional regulatory requirements.
- Understanding of Complaints, post‑market surveillance and/or Clinical report writing.
- Knowledge of Electronic Document Management systems.
Benefits
- Company events
- Company pension
- Employee discount
- Free or subsidised travel
- Free parking On‑site
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