Regulatory Affairs Specialist

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.

The Regulatory Affairs Specialist is responsible for ensuring regulatory products are registered in accordance with country specific requirements throughout the organisation.

Duties  & Responsibilities:                                                                                

• Creates and maintains global regulatory submissions to support timelines for new/modified product launches/registrations.

• Leads registrations and submissions for new and existing products.

• Ensures conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.

• Provide Regulatory Affairs support during internal and external audits.

• Liaise with regulatory authorities and Notified Bodies as required.

• Report, assess and communicate any changes in regulations.

• Provides regulatory assessment on complaints.

• Support Regulatory Affairs Manager in creation and maintenance of procedures.

• Act as mentor to junior regulatory staff members.
• Support and act as delegate for activities falling under the remit of the Regulatory Affairs Manager.

Person Specification:                                                                              

• Bachelor’s Degree in a life science or equivalent field.

• Minimum 2-5 Years’ experience within Medical Devices Regulatory or Quality.

• Ability to read and understand medical device regulatory requirements and/or standards).

• Ability to review audit reports and action accordingly.

• Understanding of post market surveillance and/or clinical report writing.

• Ability to prioritise large amounts of changing, complex workload from multiple sources and make timely and effective decisions for the execution of project objectives.

• Takes accountability for the achievement of business goals and objectives.

• Has the ability to work indepenently.

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