Graduate Regulatory Affairs Assistant

Job Description

Biocomposites, Ltd. 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 in Staffordshire, UK, it has global operations across Europe, USA, Canada, Argentina, China and India, and helps more than 1 million patients worldwide every year!

We are distinct in that our team of specialists is singularly focused on the development of innovative calcium compounds and all research, manufacture and distribution takes place at our headquarters in Keele, England. In 2022, Her Majesty the Queen honoured us with two Queen’s Awards for Enterprise in Innovation and International Trade in recognition of the impact of STIMULAN in infection cases and our outstanding continuous growth in overseas sales of more than 200% over six years. Biocomposites products are now used in over 120,000 procedures every year and sold in more than 40 countries around the world.

Job Summary

Our graduate scheme offers you access to technical, functional and behavioural skills to kick-start your career and build your network for sustained personal growth. This is a development role whereby you will provide resources for regulatory activities, whist developing a solid grounding in regulatory affairs.

We currently have 2 vacancies open.

Responsabilities:

Activities will cover the following tasks; however, the focus will be to build a solid understanding of the regulation of medical devices and the role of a regulatory affairs professional.

• Prepare and submit documents 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.

Essential requirements:

• Bachelor’s Degree in a life science or equivalent.
• Medical Devices training or qualification.
• 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.

Desirable requirements:

• Knowledge of ISO 13485.
• Knowledge of Medical Devices.
• Understanding of regional regulatory requirements.
• Understanding of Complaints, post market surveillance and/or Clinical report writing.

Location:
Keele Head Office/ Hybrid, Monday - Friday, 9.00 – 5.00/ 8.00 – 4.00, 35 hours per week.

What do we offer?

Competitive salary and benefits! With us, you will receive a competitive salary package and benefits.

We grow talent. At Biocomposites we create opportunities to thrive and grow.

One Biocomposites – team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions.

Who do we look for?

People who are passionate about what we do.

People who are open minded to evolving the way we work.

People who can work together to transform outcomes and change lives.

Benefits:

• Company events
• Company pension
• Employee discount
• Free or subsidised travel
• Free on-site parking