Graduate Regulatory Affairs Assistant

Entry-level regulatory affairs role supporting medical device compliance, documentation, and global product registrations within a healthcare company

Job Description

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.

Job Summary

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.

Reports to

A member of the Regulatory Affairs management team.

Duties & Responsibilities

Activities will cover the following tasks, however, the main 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 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.

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.

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 parking On-site