Strategic Regulatory Affairs Leader

6 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $183,985 - $212,813
About the Role

We are seeking a skilled professional to lead our regulatory product strategy team. As a key member of our organization, you will play a vital role in shaping the future of health technology.

The ideal candidate will possess deep knowledge of regulatory affairs and have a proven track record of delivering successful submissions. They will also be able to effectively communicate with cross-functional teams and drive strategic initiatives forward.

Key Responsibilities
  • Develop and execute regulatory strategies for new product introductions and product lifecycle engineering projects.
  • Collaborate with global stakeholders to define and implement regulatory pathways.
  • Lead the development of design input requirements, verification strategies, and risk documentation that meet global regulatory expectations.
  • Educate and coach the team on regulatory best practices.
Requirements
  • Bachelor's degree (or higher) in biomedical engineering, life sciences, or a related discipline.
  • 6+ years in Regulatory Affairs, with 2+ years in a leadership or mentoring capacity.
  • Proven experience supporting device submissions (e.g., FDA 510(k), CE MDR, TGA ARTG).
  • Excellent knowledge of ISO 13485, ISO 14971, 21 CFR 820, and other applicable standards.

This is an exciting opportunity to join our team and contribute to the development of innovative health technologies. If you are a motivated and experienced professional looking for a new challenge, please consider applying for this role.

  • Regulatory Affairs Strategic Leader

    4 days ago

    Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $180,000 - $240,000

    Job DescriptionThe Regulatory Affairs Strategic Lead is responsible for overseeing key regulatory activities to ensure compliance with relevant regulations and legislation.Key ResponsibilitiesProvide strategic regulatory guidance on product registration pathways, regulatory strategies, and business acquisitions to support speed to market and alignment with...

  • Strategic Regulatory Affairs Leader

    1 day ago

    Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $140,000 - $170,000

    Regulatory Affairs Manager PositionThis is an exciting opportunity for a Regulatory Affairs Manager to lead regulatory strategies and manage submissions.The ideal candidate will have expertise in regulatory affairs, specifically with prescription medicines, and be able to work collaboratively with colleagues to ensure high-quality and timely outcomes.About...

  • Regulatory Affairs Leader

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $170,000

    Job Description:This role involves leading regulatory affairs and providing strategic leadership for a portfolio of products.The ideal candidate will have extensive experience in Regulatory Affairs, preferably in prescription medicines within Australia and New Zealand, including Category 1 and New Medicine Applications.Plan and manage local regulatory...

  • Strategic Regulatory Affairs Leader

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulator Full time $140,000 - $180,000

    Regulatory Affairs Project Manager OpportunityWe are seeking a seasoned Regulatory Affairs professional to lead our portfolio of products in Australia and New Zealand.Key Responsibilities:Develop and implement regulatory strategies for product launches, ensuring compliance with local regulations.Collaborate with cross-functional teams to deliver high-quality...

  • Strategic Regulatory Affairs Leader

    1 week ago

    Sydney, New South Wales, Australia beBeeResponsibility Full time $104,000 - $130,878

    Regulatory Affairs Project Manager Job DescriptionAs a Regulatory Affairs Project Manager, you will lead a product portfolio to plan and execute regulatory strategies for local submissions in Australia and New Zealand.Key responsibilities include liaising with global, regional, and local colleagues to ensure timely and high-quality outcomes. You will also be...

  • Healthcare Regulatory Affairs Leader

    1 week ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $160,000

    Regulatory Affairs Leader for Global HealthcareThe position of Regulatory Affairs Leader for Global Healthcare involves spearheading regulatory strategy and direction for the organization within the healthcare industry. This encompasses product launch, pre-market submissions/registrations, and post-market compliance. The leader will work closely with global...

  • Strategic Regulatory Affairs Manager

    1 week ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $120,000

    Job Title: Strategic Regulatory Affairs ManagerAbout the RoleThe successful candidate will lead and support our regulatory and new product development team to ensure product registration approvals and market access, enabling business growth through strategic regulatory planning and compliance.Key Responsibilities:Manage and support the regulatory and NPD...

  • Strategic Regulatory Leader

    4 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $115,000 - $125,000

    Strategic Regulatory LeaderJob Title: Regulatory Affairs ManagerThis is a unique opportunity to shape the regulatory landscape for a growing organization.The company specializes in developing innovative therapies for patients with unmet medical needs. They have continued to grow rapidly, delivering strong commercial and clinical performance with a robust...

  • Strategic Regulatory Affairs and Product Development Director

    2 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $150,000

    Job Opportunity: Regulatory Affairs and R&D LeaderThis key position will oversee the regulatory and new product development (NPD) team to ensure timely and compliant product registrations and market access. As a strategic leader, you will drive business partnerships, develop robust regulatory strategies, and manage stakeholder engagement.

  • Head Of Regulatory Affairs

    3 days ago

    Sydney, New South Wales, Australia Nsw Icare Full time

    **Sydney CBD**- Key leadership role in icare's Stakeholder Relations and Policy Team- Lead icare's highly visible Regulatory Affairs team to build and maintain a high performing regulatory affairs function- Build and execute icare's Regulatory Affairs strategy and provide expert advice on regulatory matters to icare's Group Executive Team across our schemes-...