ANZ Regulatory Affairs Lead Specialist

1 week ago

AUSSydney O'Riordan Street F, Australia GE HealthCare Full time $80,000 - $120,000 per year
Job Description SummaryProvides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, pre-market submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally. Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market.

This position is a 12 month maternity leave contract.Job Description

Roles and Responsibilities

  • Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally
  • Utilizes in-depth knowledge of a discipline and analytical thinking to execute policy/strategy. Basic knowledge of related job disciplines.
  • Acts as a resource for colleagues with less experience. May lead small projects with low risks and resource requirements. Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.
  • Jobs at this level function with some autonomy but are subject to functional practices and precedents or are covered by well-defined policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).
  • Uses some judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions.

Required Qualifications

  • This role requires advanced experience in the Quality & Regulatory Affairs. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience).

Desired Characteristics

  • Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.
Additional Information

Relocation Assistance Provided: No

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia Heng & Hurst Full time

    We're proud to partner with a global medical technology company on an ambitious journey to become one of the world's leading device manufacturers. Their diverse product portfolio features trusted, high-quality brands that are well-established in hospitals and healthcare settings.Headquartered in Sydney and backed by a strong international network, the...

  • Head of Regulatory Affairs

    1 week ago

    Sydney, Australia HAYS Full time

    Exciting opportunity for a Head of Regulatory Affairs in consumer goods **Your new company** A global company with cutting edge medicines and consumer goods based in Sydney looking for a head of regulatory affairs to join there team in ANZ. **Your new role** You will be responsible for supporting and leading all things related to regulatory operations to...

  • Senior Specialist Regulatory Affairs

    2 weeks ago

    Sydney, New South Wales, Australia Resmed Full time $120,000 - $180,000 per year

    About ResMedThe Sydney RPSD team leads regulatory strategy and delivery for physical products where ResMed Pty Ltd is the legal manufacturer, including masks, CPAP devices, ventilators, and accessories. The team supports both New Product Introduction (NPI) and Product Lifecycle Engineering (PLE) across high-volume, global portfolios.As an individual...

  • Regulatory Affairs Lead

    2 weeks ago

    Sydney, New South Wales, Australia i-Pharm Consulting Australia Pty Ltd Full time $90,000 - $120,000 per year

    Are you a Regulatory Affairs professional ready to step into a lead role within a global, innovation-driven medical device company?This is a fantastic opportunity to join a well-established business recognised for its strong culture and high-quality products used in healthcare settings worldwide.In this role, you'll take the lead on regulatory activities...

  • Regulatory Affairs Specialist

    2 days ago

    Council of the City of Sydney, Australia black.ai Full time

    Location Melbourne HQ or Sydney Employment Type Full time Department Compliance About Heidi Heidi is on a mission to halve the time it takes to deliver world‑class care. We believe that by 2050, every clinician will practice with AI systems that free them from administrative burdens and increase the quality and accessibility of care to patients...

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, Australia Medtronic Full time

    **Careers that Change Lives **We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. Powered by our diverse knowledge, insatiable curiosity, and...

  • Senior Specialist Regulatory Affairs – Incubation

    2 weeks ago

    Sydney, New South Wales, Australia Resmed Full time $120,000 - $180,000 per year

    Job SummaryThe primary role of the Regulatory Affairs function is to provide support and guidance with respect to regulatory environment, at all stages of the life cycle of ResMed's products. Key deliverables include adding value to business through ensuring compliance and delivery of optimal regulatory strategies for portfolio planning, active regulatory...

  • Senior Specialist Regulatory Affairs – Incubation

    1 week ago

    Sydney, New South Wales, Australia Resmed Full time $80,000 - $120,000 per year

    Job SummaryThe primary role of the Regulatory Affairs function is to provide support and guidance with respect to regulatory environment, at all stages of the life cycle of ResMed's products. Key deliverables include adding value to business through ensuring compliance and delivery of optimal regulatory strategies for portfolio planning, active regulatory...

  • Regulatory Affairs Associate

    2 weeks ago

    Sydney, New South Wales, Australia EPHealthcare Full time

    Regulatory Affairs Associate – Fixed-Term Contract until the end of June 2026.Join a leading pharmaceutical company shaping the future of aestheticsAbout the CompanyOur client is a global pharmaceutical leader in the aesthetic injectable market, known for delivering science-driven innovation and high-quality products that empower both healthcare...

  • Regulatory Affairs Associate

    2 weeks ago

    Sydney, New South Wales, Australia Novo Nordisk, Inc. Full time $80,000 - $120,000 per year

    Regulatory Affairs AssociateCategory: Reg Affairs & Safety PharmacovigilanceLocation:North Sydney, New South Wales, AURegulatory Affairs AssociateClinical, Medical & Regulatory (CMR)Sydney, AustraliaAre you passionate about regulatory compliance and committed to ensuring the safety of life-changing pharmaceutical products? If you thrive in a dynamic and...