Technical Program Manager, Security & Compliance

About the role

Heidi is at the forefront of revolutionizing healthcare through artificial intelligence, and this position is vital for ensuring that our offerings adhere to international safety and security regulations. As a Technical Program Manager, you will spearhead the regulatory and security strategies, enabling Heidi to function effectively in clinical settings while managing sensitive patient information. This role requires you to distill intricate regulatory requirements into practical product specifications for our engineering teams.

Key facts

What you'll do

• Identify the necessary certifications and regulatory approvals to pursue across various markets, weighing commercial interests, risks, and engineering expenses.
• Work closely with the regulatory team to outline the roadmap for compliance with FDA, TGA, MHRA, and other emerging markets, including classification, submission processes, and post-market obligations.
• Act as the main liaison for customers, legal, clinical, commercial, product, and engineering teams regarding all aspects of safety, security, and compliance.
• Translate standards such as ISO 13485, ISO 14971, IEC 62304, SOC 2, HIPAA, and GDPR into precise product and engineering requirements.
• Lead initiatives to enhance security architecture, focusing on data management, access controls, encryption, audit logging, penetration testing, and vendor risk assessment.
• Create a scalable compliance framework that supports product expansion, moving beyond one-time audit responses to a sustainable compliance program.
• Monitor and analyze regulatory changes and trends to ensure ongoing compliance and risk management.
• Collaborate with cross-functional teams to integrate compliance into the product development lifecycle, ensuring that security and regulatory considerations are embedded from the outset.
• Prepare and deliver training sessions for internal teams on compliance best practices and regulatory requirements.
• Engage with external stakeholders, including regulatory bodies and industry groups, to advocate for Heidi's interests and stay informed about industry developments.
• Document compliance processes and maintain clear records to facilitate audits and regulatory inspections.

Requirements

• A bachelor's degree in a technical or analytical discipline such as Computer Science, Engineering, Information Systems, Biomedical Engineering, or Applied Sciences.
• A minimum of 4 years of experience in product, regulatory, or technical roles, specifically with a focus on delivered and cleared products.
• Comprehensive knowledge of medical device regulations, including FDA SaMD classification, 510(k)/De Novo pathways, TGA registration, MHRA review, ISO 13485, ISO 14971, and IEC 62304.
• Demonstrated success in developing scalable compliance programs rather than reactive audit responses.
• Ability to navigate trade-offs between documentation and product development, understanding the long-term impacts of immediate decisions.
• Skill in maintaining a clear regulatory roadmap while managing competing commercial timelines from various regional teams.
• Strong diagnostic security capabilities to evaluate customer security inquiries and pinpoint product vulnerabilities, configuration problems, or compliance issues.
• A solid understanding of software design principles, with a belief that intentional design, particularly regarding security, can greatly enhance user experience.
• Experience with AI development tools (e.g., Cursor, Claude Code) and a track record of successful outcomes.
• Familiarity with fundamental LLM concepts and their implications for regulatory risks, such as model drift, output validation, intended use, and evaluation, and the ability to translate these into compliant products.

Nice to have

• Experience in a healthcare technology company or a similar regulated environment.
• Knowledge of international regulatory frameworks beyond FDA and TGA, such as CE marking or Health Canada regulations.
• Previous experience in a startup or fast-paced environment, demonstrating adaptability and innovation.

Skills & tools

• Proficiency in project management tools and methodologies.
• Familiarity with compliance management software and security assessment tools.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal abilities, capable of engaging effectively with diverse stakeholders.

Practical notes

This position offers a hybrid work arrangement, allowing flexibility in your work environment. Benefits include a $1,000 annual budget for learning and professional development, a monthly health and wellness allowance of $150, a $500 budget for home office setup, 26 weeks of paid primary parental leave, 18 weeks of paid secondary parental leave, and fertility support up to $10,000. Additionally, employees enjoy the opportunity for four weeks of remote work from anywhere each year, along with significant equity in the company.