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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 has global operations across Europe, USA, Argentina, Canada, China, and India. Biocomposites is a world leader in the development of innovative calcium compounds and bone cements for surgical use. Its products regenerate bone and target infection risks across a variety of specialties, including musculoskeletal infection, orthopaedics, trauma, spine, foot and ankle, podiatry, and sports injuries. Biocomposites products are now used in over one million procedures per annum and sold in more than 100 countries around the world. Development role with the aim of providing a solid grounding in regulatory affairs to the post holder. In turn, they will provide resource for regulatory activities.
Job Responsibility:
Prepare and submit documents in order to maintain the Company’s site and product registrations in accordance with specified country requirements
Assess and understand the impact of design changes on regulatory compliance and maintenance of 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 with the creation of technical documentation to support product registrations
Provide general support for activities within the regulatory and compliance teams
Requirements:
Bachelor’s Degree in a life science or equivalent
Organizational 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
Nice to have:
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