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 Position

We 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 the Medical Device regulations in Australia and New Zealand.

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 TGA, Medsafe, and Corporate requirements.
  • Operate with a significant degree of efficiency and independence.
  • Manage annual reports and renewal of licenses to ensure compliance with local regulatory requirements.
  • Maintain corporate compliance by supplying information as required by the 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 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:

At Stryker, you can expect an attractive package including a range of discounts and benefits from partners. This is a genuine opportunity for an ambitious and customer-focused individual to progress and grow their career with a leading global medical device company offering development opportunities.

Benefits:

  • Multiple financial benefits including healthcare, financial wellbeing, and insurance benefits.
  • Paid parental leave schemes.
  • Volunteer Days.
  • Part of a global brand.
  • Excellent team culture.
  • Leadership support and guidance.
  • Access to career and self-development programs.
  • Collaborative work environment.

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