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
To lead regulatory activities relating to all postmarket surveillance activities for current on market implantable devices and MDR transition of Biocomposites products.
Duties & Responsibilities
- Coordinate and facilitate the generation of post market data for post market requirements.
- Aid and support the vigilance reporting for all territories and maintaining vigilance reports.
- Aid and support in the risk management activities for implantable devices.
- Prepare and review postmarket surveillance reports, postmarket clinical follow up plans and reports and review trend data according to territory requirements.
- Review and internally create and assess data trending reports, PSURs and PMS plan and reports and other regulatory documents.
- Monitor and harbour surgeon relationships for clinical data and product feedback for post market activities.
- Maintain awareness and support colleagues regarding regulatory status of products in relevant countries.
- Provide general support for activities falling under the remit of the Regulatory Affairs Clinical Data Manager.
- Act as a mentor to junior regulatory staff members
- Provide Regulatory Affairs support during internal and external audits.>
- Liaise with regulatory authorities and Notified Bodies as required.
- Support and act as delegate for activities falling under the remit of the Regulatory Affairs clinical data Manager.
- Provide regulatory assistance for medical device regulatory transitions and submissions.
Required Experience
- Bachelor’s Degree in a life science or medical field.
- 3+ years experience within Medical Devices Regulatory or Quality
- Experience with post market surveillance and reporting.
- Ability to review and appraise disparate information into comprehensible reports.
- Experience of data analysis and report writing.
- In-depth knowledge of EU MDR.
- Organisational skills and an ability to work to tight timelines.
- Proficient in the use of Microsoft Office.
- Enthusiastic and eager to learn, motivated to develop a career within Regulatory/Medical Devices.
- Commutable to the office and able to work Monday to Friday, 8/9am-4/5pm onsite minimum 4 days perweek.
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.
People 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 bus travel
- Free parking
