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 supporting the development and launch of new 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 to its employees, including multiple financial benefits, paid parental leave schemes, volunteer days, and access to our career and self-development program. As a member of our team, you will have the opportunity to work with a talented and dedicated group of professionals who are passionate about delivering high-quality medical devices to patients around the world.

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