Senior Manager, Health Care Compliance Officer
Johnson & Johnson MedTech · Raritan, NJ · 4 days ago
Hybrid$122k–$213k/yrFull-time
About the role
We are searching for the best talent for a Senior Manager, Health Care Compliance Officer within North America MedTech.
Responsibilities
- Serve as the primary Health Care Compliance business partner for the Robotics & Digital organization.
- Provide strategic guidance on commercial, medical, and business initiatives to ensure alignment with applicable laws, regulations, industry standards, and company policies.
- Partner with business leaders to incorporate compliance considerations into strategic planning and operational execution.
- Support compliant innovation and business growth through practical, risk-based solutions.
- Conduct compliance risk assessments and develop appropriate mitigation strategies.
- Identify emerging compliance risks and proactively recommend actions to address potential concerns.
- Monitor changes in the regulatory and healthcare compliance environment and assess business impact.
- Provide guidance regarding healthcare compliance, government interactions, transparency requirements, and related corporate integrity obligations.
- Support the implementation and continuous improvement of the Health Care Compliance Program.
- Establish and maintain processes, controls, and tracking mechanisms to address identified compliance risks.
- Oversee issue identification, escalation, investigation support, corrective action planning, and follow-up activities.
- Partner with Legal, Privacy, Human Resources, and other governance functions to address compliance-related concerns.
- Assess compliance education needs and develop targeted training programs and communications.
- Deliver engaging compliance training and guidance to employees and business partners.
- Communicate evolving compliance requirements, industry developments, and company expectations to key stakeholders and governance committees.
- Collaborate effectively across Health Care Compliance, Legal, Privacy, Government Affairs, Human Resources, Finance, Regulatory Affairs, and Commercial organizations.
- Influence decision-making across a matrixed organization and build strong relationships with stakeholders at all levels.
Qualifications/Requirements
- Bachelor's degree required.
- Minimum of 8 years of business-related experience.
- Minimum of 5 years of healthcare industry experience with demonstrated knowledge of:
- Health Care Compliance programs and practices
- Federal healthcare program requirements
- FDA regulatory requirements and promotional regulations
- Established experience supporting capital equipment
- Experience partnering with commercial organizations, including Sales, Marketing, Medical Affairs, or related functions
- Demonstrated ability to influence business decisions and provide strategic guidance in a complex, matrixed environment
- Proven success building strong partnerships and collaborating across functions
- Strong analytical, problem-solving, and risk-assessment skills
- Ability to translate complex regulatory and compliance concepts into practical business guidance
- Exceptional written, verbal, and presentation skills
- Demonstrated ability to manage multiple priorities and adapt in a fast-paced environment
- Experience serving as a Health Care Compliance Officer, Compliance Manager, or Governance, Risk, and Compliance leader preferred
- Experience developing, implementing, or managing key elements of a compliance program based on organizational risk assessments preferred
- Experience working directly with governmental and regulatory agencies preferred.
Preferred Skills
- Knowledge of:
- U.S. Anti-Kickback Statute
- False Claims Act
- FDA advertising and promotional requirements
- Transparency reporting requirements
- Privacy and data protection requirements
- Industry codes and standards
- Experience within the medical device, pharmaceutical, biotechnology, or broader healthcare industry preferred.