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.

This role requires a strategic thinker who can thrive in a fast-paced and high-growth company, with excellent negotiation and communication skills to build relationships with key stakeholders, industry bodies, and regulatory authorities.

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:

We offer a range of benefits, 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.

We are committed to supporting and guiding you throughout your career, with a leader who will provide guidance and mentorship.

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