Regulatory Affairs Specialist for Medical Devices

7 days ago

City Of Monash, Australia Stryker Group Full time
About the Role

As a Regulatory Affairs Lead, you will be responsible for overseeing key regulatory activities in Stryker South Pacific. This role requires ensuring compliance with relevant regulations and legislation.

This position bridges strategic and operational regulatory functions, aligning activities with business outcomes. You will serve as a subject matter expert and point of escalation for complex regulatory matters.

You will coach and mentor team members, providing guidance to support their professional development.

Key Responsibilities
  • Manage regulatory assessments and provide strategic guidance to stakeholders on product registration pathways, maximizing speed to market opportunities and aligning with business priorities.
  • Manage registration applications and variations, including high-risk submissions, ensuring compliance with relevant regulatory bodies such as the TGA and Medsafe.
  • Develop and maintain strong relationships with key stakeholders, including the TGA, Med Tech industry groups, and other regulatory bodies, to influence and advocate for favorable business outcomes.
  • Provide recommendations on regulatory strategies for navigating new regulations, standards or product changes, considering both commercial and regulatory impacts.
  • Evaluate and mitigate regulatory risks related to compliance with legislation, regulation, and corporate procedures, ensuring alignment with business goals.
  • Support the implementation of new regulatory processes and contribute to continuous improvement initiatives, enhancing RA compliance and operational efficiency.
  • Offer strategic regulatory advice on business acquisitions, ensuring smooth integration with regulatory requirements and industry standards.
Requirements
  • A minimum of 8 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.

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