Compliance Officer

Biocomposites; Newcastle-under-Lyme; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading medical devices company in the UK is seeking a Compliance Officer responsible for ensuring adherence to healthcare and corporate compliance standards. The ideal candidate will have over 8 years of experience in healthcare compliance within the pharmaceutical or medical device industry. Competitive salary and benefits offered, with opportunities for growth and team engagement.

Benefits

Company events

Company pension

Employee discount

Free or subsidised travel

Free on-site parking

Qualifications

• 8+ years healthcare compliance experience in the pharmaceutical or medical device industry.
• Demonstrated knowledge of compliance programs and industry standards.
• Ability to adapt to changing competitive challenges.

Responsibilities

• Establish and maintain an effective healthcare and corporate compliance program.
• Maintain compliance with applicable country requirements.
• Oversee investigations and respond to enforcement actions.

Skills

Healthcare compliance expertise

Knowledge of US federal fraud laws

Leadership and mentorship

Risk management

Education

Level 6 degree in scientific discipline

Job description

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 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 responses 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 (e.g., Corporate Charitable contributions, Fraud and Abuse Laws, Sunshine Act, Advamed Code of Ethics, ABHI Code of Ethics, MedTech Europe Code of Ethical Business Practice, applicable Privacy laws)
• Maintaining a current working knowledge of US Federal and State regulations and policies, and other applicable global requirements as they affect Biocomposites through routine review and monitoring of requirements

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, e.g. to attend trade exhibitions/conferences, ride along with field staff

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 on-site parking

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