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.
The Regulatory Affairs Specialist
is responsible for ensuring regulatory products are registered in accordance with country specific requirements throughout the organisation.
Responsibilities
Duties & Responsibilities
1. Creates and maintains global regulatory submissions to support timelines for new/modified product launches/registrations.
2. Leads registrations and submissions for new and existing products.
3. Ensures conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
4. Provide Regulatory Affairs support during internal and external audits.
5. Liaise with regulatory authorities and Notified Bodies as required.
6. Report, assess and communicate any changes in regulations.
7. Provides regulatory assessment on complaints.
8. Support Regulatory Affairs Manager in creation and maintenance of procedures.
9. Act as mentor to junior regulatory staff members.
10. Support and act as delegate for activities falling under the remit of the Regulatory Affairs Manager.
Person Specification
1. Bachelor’s Degree in a life science or equivalent.
2. Minimum 2-5 Years’ experience within Medical Devices Regulatory or Quality.
3. Ability to read and understand medical device regulatory requirements and/or standards.
4. Ability to review audit reports and action accordingly.
5. Understanding of post market surveillance and/or Clinical report writing.
6. Ability to prioritise large amounts of changing, complex workload from multiple sources and make timely and effective decisions for the execution of project objectives.
7. Takes accountability for the achievement of business goals and objectives.
8. Has the ability to work under minimal supervision.
9. Commutable to the office and able to work Monday to Friday, 9am-5pm.
10. Flexible approach to work.
11. Knowledge of EU Class III medical device regulation.
12. Knowledge of ISO 13485, ISO14971, ISO10993.
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.
If you are interested please forward your CV and cover letter stating the position you wish to apply for to careers@biocomposites.com
Benefits:
1. Company events
2. Company pension
3. Employee discount
4. Free or subsidised travel
5. Free parking
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