Compliance Officer

Biocomposites; England; On-site; GBP 40,000 - 60,000; Full time

Job summary

An international medical devices company is seeking a Compliance Officer to ensure adherence to regulatory requirements and maintain compliance policies. The ideal candidate will have extensive experience in a regulated industry, strong communication skills, and a commitment to ethical standards. You'll join a dynamic team focused on patient care and innovative solutions.

Benefits

Company events

Company pension

Employee discount

Free or subsidised travel

Free on-site parking

Qualifications

• Experience in a compliance, quality, or regulatory role within a regulated industry (minimum 8 years).
• Ability to prioritize tasks and accept responsibility.
• Understanding of technical attributes of products and regulatory constraints.

Responsibilities

• Maintain compliance and regulatory awareness for specified territories.
• Liaise with colleagues to ensure product regulatory status understanding.
• Lead investigations into compliance concerns and risk management.

Skills

Communication Skills

Problem Solving

Integrity

Regulatory Knowledge

Education

Level 6 degree or equivalent 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 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

Maintain regional awareness of compliance and regulatory requirements. Support the Chief Compliance Officer with upholding the Compliance Programme including investigations, auditing, monitoring & reviews.

May specialize in country requirements (e.g. US & Canada or LatAM, EU & UK or APAC, etc).

Location & Working pattern

Keele, Staffs office. Mon-Fri, 35hrs per week (e.g. 08:00-16:00 or 09:00-17:00).

Responsibilities and duties

• Maintain regional awareness of compliance and regulatory requirements applicable to the Compliance Programme including investigations, auditing, monitoring & reviews.
• Member of the Compliance Committee.
• Liaise and collaborate with departmental colleagues to ensure regulatory status of products is understood for specified territories.
• Promote a culture of ethical and business compliance through mentorship and training.
• Establish and maintain compliance policies and procedures relevant to specified territories.
• Establish routine monitoring for existing and new compliance related risks.
• Ensure company generated content (CGC) and user generated content (UGC) is monitored and reviewed to ensure claims are consistent with regulatory status of products for the target territory.
• Ensure compliance review of requests for third party organised educational events, grants and charitable donations.
• Review requests for healthcare professional (HCP) services and payments.
• Implement internal compliance audits according to the compliance audit plan.
• Lead investigations of compliance concerns including those raised under the Protected Disclosure Policy and escalate to the Chief Compliance Officer any high or critical risk concerns.
• Implement corrective or preventive actions proportionate to non-compliant findings or risks.
• Prepare regular reports on compliance matters for the Chief Compliance Officer.
• Act as Chief Compliance Officer’s delegate as required.
• Implement ad hoc compliance related projects as considered necessary.

Essential qualifications

• Level 6 degree or equivalent in scientific discipline (or 8+ years in a compliance, quality or regulatory role).

• Worked in a compliance, quality or regulatory role within a regulated industry (8+ 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.

Desirable qualifications

• Quality, regulatory or compliance related training (e.g. auditing, risk assessment, investigations).

• Worked within healthcare (medical devices or pharmaceutical) industry.

• Supervision or management of others.

• 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.

• Occasional overnight stays may be required.

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