Chief Compliance & Risk Officer Med-Tech

Jobgether

12d

About The Position

This executive role offers the opportunity to lead enterprise-wide compliance, risk management, and regulatory strategy within a rapidly scaling med-tech environment. The Chief Compliance & Risk Officer will be responsible for shaping, implementing, and maintaining robust governance frameworks that support global AI-enabled diagnostics, medical device commercialization, and clinical service operations. This role requires strategic oversight across multiple jurisdictions, ensuring regulatory compliance while enabling business growth and innovation. The position involves managing senior compliance, regulatory, and quality teams, influencing executive decision-making, and partnering closely with Legal, Finance, IT Security, and commercial functions. You will drive initiatives that protect long-term organizational value, mitigate risks, and maintain the highest ethical standards. The role includes collaboration with international teams and occasional global travel.

Requirements

• Minimum 10 years progressive experience in compliance or regulatory roles within healthcare or med-tech
• At least 5 years in senior compliance leadership positions
• Advanced degree in healthcare administration, compliance, or related field
• Professional certifications such as CHC (Certified Healthcare Compliance) or CCEP (Certified Compliance & Ethics Professional) highly desirable
• Strong understanding of IVDR/MDR, FDA regulations, ISO 13485, AI Act requirements, and global privacy frameworks
• Experience in validating software/AI in regulated environments and strategic regulatory planning
• Proven ability to lead and influence cross-functional teams and build a culture of integrity
• Excellent stakeholder management, communication, and executive advisory skills

Nice To Haves

• Deep knowledge of OIG Compliance Programs, Medicare/Medicaid regulations, Anti-Kickback Statute, Stark Law, False Claims Act, and HIPAA
• Experience building compliance programs from the ground up
• Familiarity with international AI and emerging regulatory frameworks

Responsibilities

• Lead enterprise-wide compliance, risk, and regulatory strategy across all markets, ensuring alignment with global medical device, AI, and clinical service frameworks
• Oversee Quality, Regulatory, and Data Privacy teams, architecting scalable governance and compliance frameworks
• Advise executive leadership on compliance risks, regulatory priorities, and strategic optionality for product and service offerings
• Ensure alignment of clinical, laboratory, and AI-enabled diagnostic operations with applicable US, EU, and UK regulations
• Guide regulatory submissions, clinical validation, and lifecycle compliance for AI-driven medical devices and digital pathology platforms
• Establish corporate structures, IP governance, and licensing models that balance compliance with business growth and strategic flexibility
• Act as the escalation point for integrity and compliance issues, managing confidential investigations with discretion

Benefits

• Competitive base salary with performance-based bonuses and annual increments
• Professional development opportunities and career growth support
• Healthcare benefits and pension plan with company match
• Generous annual leave and flexible work arrangements
• Opportunity to contribute to meaningful work improving patient outcomes
• Work within a collaborative, multicultural, and high-performing global team
• Exposure to cutting-edge AI and medical device technologies in a fast-paced startup environment

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Number of Employees: 11-50 employees