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: The Compliance Officer (UK) is responsible for ensuring healthcare and corporate compliance. Establishes a culture of compliance, develops and implements policies, conducts risk assessments and audits, and manages investigations related to compliance issues. Ensures adherence to laws, regulations, and ethical standards related to medical device development, manufacturing, sales, and distribution.
Duties & Responsibilities:
* Establishing and maintaining an effective healthcare and corporate compliance program in accordance with applicable guidelines and industry best practices
* Maintaining compliance with applicable country requirements, including US federal and state rules and regulations affecting the distribution of medical supplies and medical devices
* Strengthening the compliance team through line management and mentoring/development of compliance team members
* Creation/revision of applicable compliance policies, documents and deliverables
* Developing, coordinating and participating in compliance auditing and monitoring programs and risk management activities, including coordination of external third party audits
* Oversee investigations and response to internal or external enforcement actions
* Implementing KPIs to measure effectiveness of the Compliance Program
* Establishing and providing routine educational and training programs that focus on the elements of the Compliance Program
* Maintaining a current working knowledge of US Federal and State regulations and policies, and other applicable global requirements as they affect Biocomposites
Essential Qualifications:
* Level 6 degree or equivalent in scientific discipline
* 8+ years healthcare compliance experience in the pharmaceutical or medical device industry
* Demonstrated knowledge and understanding of the required elements of compliance programs and applicable industry standards
* Awareness of US federal fraud and abuse laws and guidance
* Demonstrated ability to adapt to and lead through changing competitive challenges
* Able to travel on occasions
What do we offer?:
* Competitive salary and benefits
* Opportunities to thrive and grow
* Engaged and inclusive global teams
Benefits:
* Company events
* Company pension
* Employee discount
* Free or subsidised travel
* Free on-site parking
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