Technical Program Manager, Security & Compliance
Heidi
Technical Program Manager, Security & Compliance
Heidi is seeking a Technical Program Manager for Security & Compliance to lead regulatory and security initiatives across US, UK, and Australia. The role involves translating medical device regulations into product requirements, driving certifications, and building scalable compliance programs. Requires fluency in FDA SaMD, TGA, MHRA, ISO 13485, ISO 14971, IEC 62304, SOC 2, HIPAA, and GDPR.
Technical Program Manager, Security & Compliance
Heidi is seeking a Technical Program Manager for Security & Compliance to lead regulatory and security initiatives across US, UK, and Australia. The role involves translating medical device regulations into product requirements, driving certifications, and building scalable compliance programs. Requires fluency in FDA SaMD, TGA, MHRA, ISO 13485, ISO 14971, IEC 62304, SOC 2, HIPAA, and GDPR.
Salary
Core Qualifications
Technical (Must-have)
Soft Skills
Key Responsibilities
- Drive which certifications and regulatory clearances to pursue, in which markets, in what order
- Work closely with the regulatory team to unpack the roadmap across FDA, TGA, MHRA and emerging markets
- Act as the liaison between customers, legal, clinical, commercial, product and engineering on safety, security or compliance
- Translate requirements of ISO 13485, ISO 14971, IEC 62304, SOC 2, HIPAA and GDPR into product specs and engineering standards
- Drive the security architecture forward — data handling, access controls, encryption, audit logging, penetration testing cadence, vendor risk management
- Build the compliance infrastructure that scales