ANZ Regulatory Affairs Lead Specialist

2 weeks ago

Sydney, New South Wales, Australia GE Healthcare Full time $90,000 - $120,000 per year

*Job Description Summary*

Provides 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

  • Anz Regulatory Affairs Lead Specialist

    2 weeks ago

    Sydney, New South Wales, Australia I00960 Ge Healthcare Australia Pty Limited Full time

    ANZ Regulatory Affairs Lead Specialist page is loaded ANZ Regulatory Affairs Lead Specialist Apply locations AUS08-01-Sydney-241 O'Riordan Street, 8F time type Full time posted on Posted Yesterday job requisition id R Job Description Summary Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for...

  • Anz Regulatory Affairs Lead Specialist

    2 weeks ago

    Sydney, New South Wales, Australia Buscojobs Full time

    ANZ Regulatory Affairs Lead Specialist page is loaded ANZ Regulatory Affairs Lead Specialist Apply locations AUS08-01-Sydney-241 O'Riordan Street, 8 F time type Full time posted on Posted Yesterday job requisition id R4028130 Job Description Summary Provides regulatory strategy and direction to the business regarding healthcare industry regulatory...

  • Anz Regulatory Affairs Lead Specialist

    3 weeks ago

    Sydney, New South Wales, Australia Buscojobs Full time

    ANZ Regulatory Affairs Lead Specialist page is loadedANZ Regulatory Affairs Lead SpecialistApply locations AUS08-01-Sydney-241 O'Riordan Street, 8F time type Full time posted on Posted Yesterday job requisition id R4028130Job Description SummaryProvides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements...

  • ANZ Regulatory Affairs Lead Specialist

    3 weeks ago

    Sydney, New South Wales, Australia I00960 GE Healthcare Australia Pty Limited Full time

    ANZ Regulatory Affairs Lead Specialist page is loadedANZ Regulatory Affairs Lead SpecialistApply locations AUS08-01-Sydney-241 O'Riordan Street, 8F time type Full time posted on Posted Yesterday job requisition id R4028130Job Description SummaryProvides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements...

  • ANZ Regulatory Affairs Lead Specialist

    2 weeks ago

    Sydney, New South Wales, Australia I00960 GE Healthcare Australia Pty Limited Full time

    ANZ Regulatory Affairs Lead Specialist page is loadedANZ Regulatory Affairs Lead SpecialistApply locations AUS08-01-Sydney-241 O'Riordan Street, 8F time type Full time posted on Posted Yesterday job requisition id R4028130Job Description SummaryProvides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements...

  • Anz Regulatory Affairs Lead Specialist

    1 week ago

    Sydney, New South Wales, Australia I00960 Ge Healthcare Australia Pty Limited Full time

    ANZ Regulatory Affairs Lead Specialist page is loadedANZ Regulatory Affairs Lead SpecialistApply locations AUS08-01-Sydney-241 O'Riordan Street, 8F time type Full time posted on Posted Yesterday job requisition id R4028130Job Description SummaryProvides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements...

  • Special Projects Regulatory Affairs Lead, Anz

    2 weeks ago

    Sydney, New South Wales, Australia Johnson & Johnson Full time

    **Job Function**:Regulatory Affairs Group**Job Sub Function**:Regulatory Affairs**Job Category**:Professional**All Job Posting Locations**:North Ryde, New South Wales, Australia**About MedTech**Fuelled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalised...

  • Regulatory Affairs Lead

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $130,000

    We are seeking a seasoned Regulatory Affairs Manager to lead and manage regulatory affairs for listed medicines across Australia and New Zealand.This is an exciting opportunity to oversee day-to-day operations, strategic planning, and cross-functional collaboration, while fostering a high-performance team culture.Develop and implement regulatory strategies...

  • Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia Boston Scientific Corporation Full time

    **Work mode**:Hybrid**Onsite Location(s)**:Mascot, AU**Hiring Manager**: Juan Sebastian Castiblanco**Recruiter**: Aislinn Roche**ABOUT THE ROLE**- We are seeking an enthusiastic and skilled regulatory specialist to join our Australia and New Zealand (ANZ) Regulatory Affairs team. This role offers a great opportunity with a global medical device leader to...

  • Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia Pepsico Full time

    OverviewJoin PepsiCo in Chatswood, New South Wales, Australia as a Regulatory Affairs Specialist. Work for a global FMCG company with trusted and iconic brands and contribute to regulatory excellence for the Australia and New Zealand region.The primary purpose of this position is to ensure regulatory compliance of all PepsiCo food products, including...