Senior Legal & Compliance Counsel

Overview

The organization is seeking a Senior Legal & Compliance Counsel – US to provide legal advice to US leadership and support the development and implementation of the US compliance program.

This role acts as a trusted advisor to enable compliant commercial growth, support continued US market entry, and strengthen legal and compliance governance across the US. The position requires both strategic involvement and hands-on execution in a highly regulated medical device environment.

Responsibilities

Legal & Compliance Leadership

• Support the development and implementation of the US compliance program in alignment with corporate objectives.
• Design, execute, and oversee the annual Compliance Workplan, including risk assessment, monitoring, audits, and remediation.
• Advise leadership on legal and compliance risk with clear, business-focused recommendations.
• Support US Quality and Regulatory legal and compliance matters (e.g. FDA, QMS, MDR).
• Ensure compliance with applicable healthcare, medical device, and anti-corruption laws in the US, including:
  • FCPA, AKS, False Claims Act, Stark Laws, Sunshine Act (transparency)
  • HIPAA and privacy & cybersecurity laws
  • Anti-trust (FTC)
  • Reimbursement (Medicare / Medicaid)
  • Medical research and clinical trials regulations

Ethics, Compliance & Transparency

• Own the development and implementation of the US compliance program, including training of employees on Codes of Conduct and HCP / HCI compliance policies.
• Support rollout and adoption of HCP engagement and transparency solutions.
• Support accurate and timely transparency and disclosure reporting.
• Support third-party risk management, including due diligence, contracting standards, training, and audits.
• Lead or support internal investigations and remediation as required.

Commercial & Contracting

• Negotiate and execute commercial, distribution, clinical, and consulting agreements.
• Develop scalable contract templates and legal processes to support commercial models, including CAPEX and OPEX sales.
• Partner with Commercial, Finance, Marketing, Professional Education and Medical Affairs to enable compliant revenue growth.
• Manage disputes and litigation (possibly with external counsel involvement), focusing on risk mitigation and cost efficiency.

Regulatory, Quality & Privacy

• Support Regulatory and Quality teams on market access, clinical trials, and regulatory compliance.
• Provide legal guidance on product safety, complaints, adverse events, and field actions.
• Advise on privacy and data protection matters in collaboration with IT and Data Protection leadership.

Corporate Governance

• Perform company secretarial responsibilities.
• Advise on corporate governance and support Board and committee processes.
• Contribute to preparation of Board and Executive materials.
• Support entity management and statutory compliance activities.

Regional Leadership (US)

• Lead legal and compliance support for U.S. market entry and commercialization.
• Negotiate clinical trial agreements and budgets with PSSC and research sites.
• Develop and maintain policies ensuring compliance with U.S. healthcare fraud and abuse laws, including AKS.
• Act as primary legal and compliance partner to US leadership.
• Embed Legal and Compliance into regional operating rhythms and decision-making.
• Drive adoption of approved commercial and compliance templates.
• Deliver compliance training to employees and distributors.
• Conduct risk-based third-party audits.
• Oversee external counsel, improving effectiveness and reducing external legal spend.

Requirements

• Juris Doctor (JD) or equivalent legal qualification; active US bar membership.
• Significant experience in the MedTech industry, healthcare, medical devices, or similarly regulated industries.
• Demonstrated leadership of US legal and compliance operations.
• Deep knowledge of HCP engagement regulations, anti-corruption laws, transparency reporting, and third-party risk.
• Strong cross-functional communication and stakeholder management skills.
• Experience working across the US.
• Strong legal judgment with commercial mindset.
• Proven contract negotiation and drafting capability.
• Proven ability to develop and implement US compliance programmes.
• High-level communication and influencing skills.
• Ability to translate regulatory requirements into pragmatic business solutions.
• Must be located in the US.

Eligibility to work: This role requires candidates to have eligibility to work within the USA.

Agency notice: Strictly no agencies.

Location

United States