Current jobs related to High-Impact Product Launch Regulatory Affairs Specialist - Sydney, New South Wales - beBeeRegulatoryAffairs

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $120,000

    Job Title: Regulatory Affairs SpecialistThis position is ideal for a detail-oriented individual with a passion for regulatory affairs in the cosmetics industry.Key Responsibilities:Build and maintain a master database of products to ensure compliance with the Australia Industrial Chemical Introduction Scheme (AICIS).Collaborate with marketing, supply, and...

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $80,000 - $150,000

    Regulatory Affairs SpecialistWe are seeking a skilled Regulatory Affairs professional to drive innovation and develop new products for our major brands.The ideal candidate will have 3-4 years' experience in a similar role, a degree in a scientific field, and experience within the consumer goods industry. They will also have exposure to cosmetics, medical...

  • Senior Regulatory Affairs Expert for Medical Device Launch

    6 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $115,000 - $130,000

    Regulatory Affairs Expert for Medical Device Launch">As a key member of the Regulatory Affairs team, you will be instrumental in ensuring efficient, compliant, and timely pre-market submissions. This is an exciting opportunity to support a high-priority product portfolio during a critical period of growth.Key Responsibilities:Manage end-to-end regulatory...

  • Healthcare Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $180,000

    Healthcare Regulatory Affairs SpecialistThis position is a 12 month maternity leave contract.Job Description:We are seeking a Healthcare Regulatory Affairs Specialist to provide regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, pre-market submissions/registrations and post market...

  • Regulatory Affairs Professional

    1 week ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $125,000 - $165,000

    Regulatory Affairs SpecialistA key member of our team, the Regulatory Affairs Specialist is accountable for providing regulatory affairs knowledge and support to ensure our business meets its objectives.Delivering product pre-market approval within the timeframe, post-market vigilance and maintenance of all related regulatory activities requires dedication...

  • Healthcare Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $140,000

    Regulatory Strategy and Compliance RoleThis position involves providing strategic guidance to the business on regulatory requirements for product launches, submissions, and post-market compliance in the healthcare industry. The successful candidate will work closely with global healthcare regulatory bodies to ensure compliance with industry standards.The...

  • Regulatory Affairs Specialist

    1 week 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

    1 week ago

    Sydney, New South Wales, Australia Bio-Rad Laboratories Full time

    Overview: A key member of the Regulatory Affairs Function, accountable for providing regulatory affairs knowledge and support the business meeting its objectives, as well as regional RA activities.Delivering product pre market approval within the timeframe, post-market vigilance and maintenance of all related regulatory activities obtain necessary regulatory...

  • 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...

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $80,000 - $120,000

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for supporting regulatory affairs activities for assigned products in Australia and New Zealand.Main Responsibilities:Support Regulatory Activities: Ensure compliance with all relevant regulations while assisting in developing strategies...

High-Impact Product Launch Regulatory Affairs Specialist

2 weeks ago

Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $120,000 - $130,000
Regulatory Affairs Specialist

This role plays a critical part in ensuring efficient and compliant pre-market submissions for our product portfolio during a period of growth.

The successful candidate will be responsible for managing end-to-end regulatory submissions, including interactions with the Therapeutic Goods Administration (TGA), leading regulatory strategy, and compiling technical files primarily adapted from EU documentation.

Key responsibilities include preparing documentation for high-class devices: Class III IVD, Class IIb, and Class III Medical Devices. The role also involves reviewing local documentation, assessing non-conformance where required, evaluating the regulatory impact of product and process changes, and reviewing promotional and advertising materials for compliance.

A strong focus on regulatory affairs is essential, with experience in managing TGA submissions and promoting material reviews being highly desirable. Additionally, the ideal candidate will possess intelligent, adaptable, and strong communication skills, as well as the ability to manage priorities in a fast-paced setting.

Requirements
  • Tertiary qualification in a scientific or healthcare-related discipline
  • Minimum 3 years of Regulatory Affairs experience in medical devices
  • Strong technical writing experience, especially with regulatory files
  • Experience working on TGA submissions and promotional material reviews

A collaborative environment values innovation, autonomy, and open communication. This culture fosters big-picture thinkers who also dive deep into detail, supported by a leadership style that balances hands-off guidance with emotional maturity and self-management.

About the Opportunity

This is an exciting opportunity to contribute to a high-impact product launch and play a vital role in regulatory strategy and operations for the ANZ region.