What are the responsibilities and job description for the Compliance Associate position at Biocomposites?
Job Description
Biocomposites, Inc., a US company based in Wilmington, NC is a subsidiary of Biocomposites, Ltd., an international medical devices company that engineers, manufactures and markets world leading calcium compounds, including STIMULAN, a truly absorbable calcium sulfate recrystallized for use in the presence of infection. Based in Keele, UK, it has global operations across USA, Canada, Europe, China and India.
At Biocomposites we are proud of our series of world firsts. For us, innovation is an ongoing process. Our continuing investment in proprietary technologies has resulted in over 100 IP grants and registrations and positioned us at the frontier of musculoskeletal infection, trauma, spine and sports injuries.
Our products target a broad spectrum of devices ranging from bone grafts to matrices that can be used in the presence of infection. Possessing unique characteristics for regenerating bone and managing dead space, our products are opening new possibilities for surgeons around the world.
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 honored 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
Support the local Compliance Officer with day-to-day administration of the Compliance Programme including auditing, monitoring & reviews. May specialise in country requirements (e.g. US & Canada or LatAM, EU & UK or APAC, etc)
Responsibilities
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
Biocomposites, Inc., a US company based in Wilmington, NC is a subsidiary of Biocomposites, Ltd., an international medical devices company that engineers, manufactures and markets world leading calcium compounds, including STIMULAN, a truly absorbable calcium sulfate recrystallized for use in the presence of infection. Based in Keele, UK, it has global operations across USA, Canada, Europe, China and India.
At Biocomposites we are proud of our series of world firsts. For us, innovation is an ongoing process. Our continuing investment in proprietary technologies has resulted in over 100 IP grants and registrations and positioned us at the frontier of musculoskeletal infection, trauma, spine and sports injuries.
Our products target a broad spectrum of devices ranging from bone grafts to matrices that can be used in the presence of infection. Possessing unique characteristics for regenerating bone and managing dead space, our products are opening new possibilities for surgeons around the world.
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 honored 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
Support the local Compliance Officer with day-to-day administration of the Compliance Programme including auditing, monitoring & reviews. May specialise in country requirements (e.g. US & Canada or LatAM, EU & UK or APAC, etc)
Responsibilities
- Day-to-day administration of the Compliance Programme including auditing, monitoring & reviews.
- Liaise and collaborate with departmental colleagues to ensure regulatory status of products is understood for specified territories.
- Support Compliance Officer in management of existing and new compliance related risks.
- Review and monitor company generated content (CGC) to ensure claims are consistent with regulatory status of products for the target territory.
- Content may be written, visual or spoken (i.e., voice-over in commercial videos).
- Review and monitor user generated content (UGC) related to company’s products for compliance.
- Support Compliance Officer in review of requests for third party organised educational events, grants and charitable donations.
- Conduct internal compliance audits according to the compliance audit plan.
- Report to the Compliance Officer identified non-compliant finding and take necessary action as advised.
- Additional resource for ad hoc compliance related projects.
- Level 6 degree or equivalent in scientific discipline (or 3 years in a compliance, quality or regulatory role).
- Worked in a compliance, quality or regulatory role within a regulated industry 3 years minimum.
- Able to understand technical attributes of products and marketing limitations associated with regulatory and/or data quality and integrity.
- Excellent verbal, non-verbal and written communication skills. Accepts responsibility and able to prioritise tasks. Ability to make complex concepts understandable. High ethical standards and integrity.
- Able to travel on occasions, e.g. to attend trade exhibitions/conferences, ride alongs with field staff.
- Any quality, regulatory or compliance related training (e.g. auditing, risk assessment).
- Worked within healthcare (medical devices or pharmaceutical) industry.
- Working knowledge of QMS / GMP / Compliance principles (e.g. ISO 13485, 21CFR820, OIG GCPG).
- Able to act both automatously and engage within a team. Able to use initiative whilst recognising boundaries of own knowledge.
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