About the Role The Senior Legal & Compliance Counsel - US is a legal and compliance role responsible for providing legal advice to CMR US and supporting the development and implementation of CMR US' compliance program.
The role serves as a trusted advisor to CMR US' leadership, enabling compliant commercial growth, supporting continued US. market entry, and strengthening legal and compliance governance across the US.
This position requires both strategic involvement with hands on execution in a highly regulated medical device environment.
Responsibilities Legal & Compliance Leadership - Support the development and implementation of CMR 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 on legal and compliance aspects of Quality and Regulatory matters in the US (e.g. FDA, QMS, MDR).
- Ensure compliance with applicable healthcare, medical device, and anti-corruption laws in the US, e.g. 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 e.g. 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 - Negotiation and execution of 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 - 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.
The role requires flexibility and a willingness to operate across the full scope of the legal and compliance remit to support CMR Surgical's growth in the US.
We'd expect you to be willing to turn your hand to anything within the legal and compliance remit that helps the team deliver its objectives.
About you To be successful in this role, you'll need to have/be:
- 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
Interested? We'd love to hear from you! This role requires candidates to have eligibility to work within the USA.
Strictly no agencies 
