Role descriptionRole: Compliance and Regulatory Affairs Officer
Package: Competitive basic salary plus generous benefits package
Location: Cambridgeshire Head Office
Our client is worlds leading MedTech company with a strong record for product and service innovation. Working in close Partnership with the NHS and individual healthcare professionals to improve outcomes for people with intimate healthcare needs. A people focused organisation who offer great career opportunities plus a strong benefits package for staff. They are proud to be listed in the Sunday Times Best Companies to work for in the UK, and offer great career opportunities plus a strong benefits package for staff.
The Compliance and Regulatory Affairs Officer is a brand-new role in the UK Business. The position reports to the Global Corporate Compliance Officer with a dotted line to the UK Country Manager.
The role offers a high degree of autonomy together with the opportunity to be at the forefront of commercial decisions to support and drive business priorities. You will manage the implementation of global policies in the UK, offer proactive counsel on all areas of responsibility to the Senior Leadership team and will report to the Directors on strategic compliance initiatives.
To be successful in this role you will be able to work strategic, tactical and operational levels. You will be impactful, influential and solution orientated with an excellent ability to manage multiple stakeholders. You will have a strong desire to have a thorough commercial understanding, with a robust drive, determination and resilience.
Key Accountabilities will include:
Provide policies, guidance and operational procedures to ensure operational and clinical compliance
Be a subject matter expert on several key compliance and regulatory areas
Code of conduct and other global compliance policies (incl. Business Ethical Standards)
MedTech Europe Standards and regulations
UK & Republic of Ireland regulatory guidelines and frameworks
Data protection and GDPR
Bribery act, Modern Slavery Act and other regulation on Business Ethics Compliance
Compliance best practices
Chair UK/ Republic of Ireland MedTech Grants Committee
Manage UK/Republic of Ireland Pool of Qualified HCPs in line with MedTech requirement, in close collaboration with Heads of Education
Provide regular updates and interpretations of the UK/RoI Pharma Regulations to create an operating framework
Provide support and guidance with the creation of external communications related to compliance and regulatory matters
Local compliance and data protection risk assessments and mitigation plans
Implement global and regional compliance initiatives