Heidi Health

1 day ago

Technical Program Manager, Security & Compliance

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 28 minutes agoStatus: Live

Job Summary

Own the regulatory and security roadmap that enables clinical AI deployment as a medical device. Translate FDA SaMD classification, TGA registration, MHRA review, and post-market obligations into product requirements and engineering standards. Partner with legal, engineering, clinical, and commercial teams to turn ISO 13485, ISO 14971, IEC 62304, SOC 2, HIPAA, and GDPR into scalable compliance infrastructure, balancing market risk, timelines, and security architecture.

Location: Melbourne, Sydney

Workplace: Hybrid

Employment Type: Full time

Job Function: Program & Project Management (PMO)

Seniority: Mid level

Key Responsibilities

•Help decide which certifications and regulatory clearances to pursue across markets, in what order, balancing commercial urgency, regulatory risk, and engineering cost.
•Partner with the regulatory team to unpack the roadmap across FDA, TGA, MHRA, and emerging markets, including classification, submission strategy, and post-market obligations.
•Act as a liaison across customers, legal, clinical, commercial, product, and engineering on safety, security, and compliance.
•Translate ISO 13485, ISO 14971, IEC 62304, SOC 2, HIPAA, and GDPR requirements into product specs and engineering standards.
•Drive the security architecture forward and build scalable compliance infrastructure (data handling, access controls, encryption, audit logging, penetration testing cadence, and vendor risk management).

Pay and Benefits

Perks:Learning BudgetWellness StipendHome OfficeParental LeaveFertility SupportEquity

Key Requirements

•BA/BS in a technical or analytical field (e.g., Computer Science, Engineering, Information Systems, Biomedical Engineering, Applied Sciences).
•4+ years in product, regulatory, or technical roles; focus on what you’ve shipped and cleared.
•Real fluency with medical device regulation, including FDA SaMD classification (510(k)/De Novo), TGA registration, MHRA review, ISO 13485, ISO 14971, and IEC 62304.
•Experience building compliance programs that scale into durable architecture, not one-off audit responses.
•Diagnostic security fluency and the judgment to triage security questionnaire gaps (product gap vs configuration vs compliance theatre).

Experience:4+ years

Education:Bachelor's

Skills:JudgmentCommunicationStakeholder liaisonLeadershipStrategic thinking

Tech Stack:FDA SaMD510(k)De NovoTGAMHRAISO 13485ISO 14971IEC 62304SOC 2 Type IIHIPAAGDPRCursorClaude CodeLLM conceptsEncryptionAudit loggingPenetration testingVendor risk management

Company Brief

Heidi Health

Builds an AI medical scribe and clinical productivity platform that automates documentation, form-filling, and task management to expand clinician capacity across hospitals, GP clinics and specialist services worldwide.

Industry: HealthTech

Company Size: Medium (51 to 250 employees)

Growth: Scaleup

Valuation: USD 250M to 500M

Funding: Series B

Headquarters: Melbourne, Australia

Founded: 2019

Glassdoor: 4.7

Website LinkedIn Glassdoor

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Heidi Health

1 day ago

Technical Program Manager, Security & Compliance

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 28 minutes agoStatus: Live

Job Summary

Location: Melbourne, Sydney

Workplace: Hybrid

Employment Type: Full time

Job Function: Program & Project Management (PMO)

Seniority: Mid level

Key Responsibilities

•Help decide which certifications and regulatory clearances to pursue across markets, in what order, balancing commercial urgency, regulatory risk, and engineering cost.
•Partner with the regulatory team to unpack the roadmap across FDA, TGA, MHRA, and emerging markets, including classification, submission strategy, and post-market obligations.
•Act as a liaison across customers, legal, clinical, commercial, product, and engineering on safety, security, and compliance.
•Translate ISO 13485, ISO 14971, IEC 62304, SOC 2, HIPAA, and GDPR requirements into product specs and engineering standards.
•Drive the security architecture forward and build scalable compliance infrastructure (data handling, access controls, encryption, audit logging, penetration testing cadence, and vendor risk management).

Pay and Benefits

Perks:Learning BudgetWellness StipendHome OfficeParental LeaveFertility SupportEquity

Key Requirements

•BA/BS in a technical or analytical field (e.g., Computer Science, Engineering, Information Systems, Biomedical Engineering, Applied Sciences).
•4+ years in product, regulatory, or technical roles; focus on what you’ve shipped and cleared.
•Real fluency with medical device regulation, including FDA SaMD classification (510(k)/De Novo), TGA registration, MHRA review, ISO 13485, ISO 14971, and IEC 62304.
•Experience building compliance programs that scale into durable architecture, not one-off audit responses.
•Diagnostic security fluency and the judgment to triage security questionnaire gaps (product gap vs configuration vs compliance theatre).

Experience:4+ years

Education:Bachelor's

Skills:JudgmentCommunicationStakeholder liaisonLeadershipStrategic thinking

Tech Stack:FDA SaMD510(k)De NovoTGAMHRAISO 13485ISO 14971IEC 62304SOC 2 Type IIHIPAAGDPRCursorClaude CodeLLM conceptsEncryptionAudit loggingPenetration testingVendor risk management

Company Brief

Heidi Health

Industry: HealthTech

Company Size: Medium (51 to 250 employees)

Growth: Scaleup

Valuation: USD 250M to 500M

Funding: Series B

Headquarters: Melbourne, Australia

Founded: 2019

Glassdoor: 4.7

Website LinkedIn Glassdoor