Regulatory Affairs Specialist

4 weeks ago

Sydney, New South Wales, Australia Stryker Australia Pty Ltd Full time
Senior Regulatory Affairs Associate

Stryker Australia Pty Ltd is seeking a highly skilled and experienced Senior Regulatory Affairs Associate to join our high-performing regulatory team. As a key member of our team, you will play a critical role in ensuring compliance with regulatory requirements and ensuring the successful registration of our medical devices.

Key Responsibilities:
  • Prepare and submit device registration applications, including complex submissions such as Class III and/or TGA Conformity Assessment applications.
  • Review and determine the impact of change notifications for existing devices, including management of registration updates and stakeholder communication.
  • Provide strategic regulatory advice and transfer management for smooth incorporation of product acquisitions.
  • Work closely with key stakeholders to process regulatory actions in accordance with the Therapeutic Goods Administration (TGA), Medsafe and Corporate requirements.
  • Operate with a significant degree of efficiency and independence.
  • Management of annual reports and renewal of licenses to ensure compliance with local regulatory requirements.
  • Maintain corporate compliance by supplying information as required by the Therapeutic Goods Administration (TGA) and Medsafe.
  • Develop new regulatory processes and continuous process improvements.
  • Develop and maintain strong relationships with MedTech Industry and the TGA to leverage advocacy opportunities including health policy in line with the business strategy.
  • RA Assistant/Associate level mentorship.
Requirements:
  • Minimum 5 years' experience in a similar Regulatory Affairs role.
  • Tertiary education in a technical discipline (e.g. Science, Engineering, Biomedical or related).
  • High attention to detail and deadline oriented.
  • Self-driven, strategic thinker with the ability to thrive in a fast-paced and high growth company.
  • Proven experience in Regulatory Affairs with demonstrated success in the analysis and interpretation of regulatory documentation and technical writing.
  • Strong knowledge of the Medical Device regulations in Australia and New Zealand. International regulatory knowledge desirable e.g. FDA and EU MDR.
  • Strong negotiation and communication skills to effectively build relationships with key stakeholders, industry bodies and regulatory authorities.
Culture and Benefits:

Stryker offers a range of benefits and discounts from a range of partners, including multiple financial benefits, paid parental leave schemes, volunteer days, and access to our career and self-development program from day one. As a member of our team, you will have the opportunity to work with likeminded individuals who are driven by exceeding targets and improving patient outcomes.

  • Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia Novartis Full time

    Regulatory Affairs Role OverviewWe are seeking a highly experienced Regulatory Affairs Specialist to join our team at Novartis. As a key member of our team, you will play a critical role in determining the optimal regulatory pathway to accelerate the approval process.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with...

  • Regulatory Affairs Specialist

    2 weeks ago

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

    Regulatory Affairs Specialist Position OverviewJohnson & Johnson is currently seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs team, you will play a critical role in supporting our business growth by providing regulatory leadership of a portfolio of products.Main Responsibilities:Lead a...

  • Regulatory Affairs Specialist

    4 weeks ago

    Sydney, New South Wales, Australia Healthcare Professionals Group Full time

    About the Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team as a Senior Consultant. As a key member of our Regulatory, Quality & Compliance team, you will be responsible for managing complex regulatory projects for clients in Australia, New Zealand, and the JAPAC region.Key Responsibilities:Develop and implement regulatory...

  • Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia PharmaLex Full time

    Regulatory Affairs Role OverviewWe are seeking an experienced Regulatory Affairs Professional to join our Pharmaceutical Regulatory Consulting team in Australia.In this role, you will work with a broad range of clients, predominantly in the pharmaceutical and health care sectors, to ensure licensing, marketing, and regulatory compliance of products.You will...

  • Regulatory Affairs Specialist

    3 weeks ago

    Sydney, New South Wales, Australia Device Technologies Australia Pty Ltd Full time

    About us...At Device Technologies Australia Pty Ltd, we are dedicated to delivering innovative solutions to the healthcare industry. Our commitment to quality, safety, and efficacy is unwavering, and we are seeking a skilled Regulatory Affairs Specialist to join our team.The opportunity...You will be responsible for a portfolio of medical devices, ensuring...

  • Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia Reckitt Benckiser Australia Full time

    We are Reckitt, a global leader in hygiene, health, and nutrition. Our purpose is to protect, heal, and nurture in the relentless pursuit of a cleaner, healthier world.As a Regulatory Affairs Specialist, you will be responsible for shaping the synergy between our innovative products and the regulatory framework that guides them.This role offers the...

  • Regulatory Affairs Director

    4 weeks ago

    Sydney, New South Wales, Australia ENG Con Full time

    Job Title: Associate Director, Regulatory AffairsWe are seeking an experienced Regulatory Affairs professional to join our team in Australia.About the RoleThis is an exciting opportunity to work with a leading service company for the Pharmaceutical Industry globally. As an Associate Director, Regulatory Affairs, you will be responsible for maximizing client...

  • Regulatory Affairs Specialist

    3 weeks ago

    Sydney, New South Wales, Australia Stryker Australia Pty Ltd Full time

    We are seeking a highly skilled Senior Regulatory Affairs Associate to join our high-performing regulatory team at Stryker Australia Pty Ltd.The ideal candidate will have at least 5 years of experience in Regulatory Affairs, with a strong background in Class III and TGA conformity assessment applications.Responsibilities will include preparing and submitting...

  • Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia Stryker Australia Pty Ltd Full time

    Stryker Australia Pty Ltd: Senior Regulatory Affairs Associate PositionWe are seeking a highly skilled Senior Regulatory Affairs Associate to join our high-performing regulatory team in Australia. The successful candidate will bring extensive experience in Regulatory Affairs, Class III and TGA conformity assessment applications, and a strong understanding of...

  • Regulatory Affairs Specialist

    4 weeks ago

    Sydney, New South Wales, Australia Stryker Australia Pty Ltd Full time

    We are seeking a highly skilled Senior Regulatory Affairs Associate to join our high-performing regulatory team at Stryker Australia Pty Ltd.The ideal candidate will have at least 5 years of experience in Regulatory Affairs, with a strong background in Class III and TGA conformity assessment applications.This role requires a strategic thinker who can thrive...

  • Strategic Regulatory Affairs Director

    2 weeks ago

    Sydney, New South Wales, Australia ENG Con Full time

    About the RoleWe are seeking an experienced Regulatory Affairs professional to join our Pharmaceutical Regulatory Consulting team in Australia. As a key member of our team, you will be responsible for maximizing client commercial success by ensuring appropriate licensing, marketing, and regulatory compliance of client products.Key ResponsibilitiesAdvise and...

  • Regulatory Affairs Specialist, Compliance Expert

    2 days ago

    Sydney, New South Wales, Australia Reckitt Benckiser Australia Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Reckitt Benckiser Australia. This is an exciting opportunity to work with innovative products and shape the synergy between our offerings and the regulatory framework that governs them.In this role, you will be responsible for interpreting and implementing...

  • Regulatory Affairs Expert

    4 weeks ago

    Sydney, New South Wales, Australia PharmaLex Full time

    Your RoleWe are seeking an experienced Regulatory Affairs professional to join our team at PharmaLex Australia. In this role, you will have the opportunity to work with a diverse range of clients in the pharmaceutical and healthcare sectors. Your primary objective will be to ensure regulatory compliance and maximize client commercial success by advising on...

  • Senior Regulatory Affairs Specialist

    4 weeks ago

    Sydney, New South Wales, Australia Astra Zeneca Full time

    AstraZeneca is seeking a Senior Regulatory Affairs Associate to join our team in Australia. As a key member of our Regulatory Affairs team, you will play a critical role in preparing and executing regulatory submission plans and implementing the agreed regulatory strategy to register and maintain products across a range of therapeutic areas.About the...

  • Regulatory Affairs Director

    3 weeks ago

    Sydney, New South Wales, Australia Ethos BeathChapman Full time

    Senior Manager - Group Regulatory AffairsEthos BeathChapman is seeking a seasoned professional to lead their Regulatory Affairs team. This is an exceptional opportunity to contribute to regulatory strategy, build relationships with key regulators, and provide strategic insights to senior leadership.The Role:As a Senior Manager in Group Regulatory Affairs,...

  • Regulatory Affairs Strategist

    4 weeks ago

    Sydney, New South Wales, Australia Ethos BeathChapman Full time

    Senior Manager - Group Regulatory AffairsEthos BeathChapman is seeking an accomplished professional to join their Regulatory Affairs team. This role offers the chance to contribute to regulatory strategy, build relationships with key regulators, and provide strategic insights to senior leadership.The Role:As a Senior Manager in Group Regulatory Affairs, you...

  • Senior Regulatory Affairs Manager

    3 weeks ago

    Sydney, New South Wales, Australia PharmaLex Full time

    Your RoleWe have an opportunity for an experienced Regulatory Professional to join our team in Australia. As a Seasoned Regulatory Affairs Specialist, you will be responsible for ensuring the compliance of products with regulatory requirements. Your primary objective is to maximize commercial success by advising clients on licensing, marketing, and...

  • Regulatory Affairs Engineer

    3 weeks ago

    Sydney, New South Wales, Australia ResMed Full time

    The Regulatory Affairs function at ResMed plays a vital role in ensuring our products meet regulatory requirements. As a Student Regulatory Affairs Professional, you will be part of the Regulatory Affairs - Systems and Business Excellence Team located in Sydney, working closely with internal stakeholders and external regulators to achieve business goals.You...

  • Legal Counsel, Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia Reckitt Benckiser Australia Full time

    Reckitt is a global leader in the health, hygiene, and nutrition sectors. We're seeking a talented legal counsel to join our team as a Legal Counsel, Regulatory Affairs Specialist. In this role, you'll be responsible for managing a broad spectrum of legal affairs, ensuring Reckitt operates within the framework of compliance and integrity. Your expertise will...

  • Regulatory Affairs Specialist

    3 weeks ago

    Sydney, New South Wales, Australia Device Technologies Australia Pty Ltd Full time

    About Device Technologies Australia Pty Ltd...We are dedicated to improving patients' lives through leading-edge technology and services, supplying hospitals and healthcare professionals with high-calibre medical solutions from around the world.Our culture is built on empowering our people to achieve their goals, aligning with wider business objectives. We...