Regulatory Compliance Specialist

1 day ago

Sydney, New South Wales, Australia beBeeRegulatory Full time
Job Description">

The Regulatory Affairs Lead is responsible for overseeing and driving key regulatory activities, ensuring compliance with relevant regulations.

This role bridges strategic and operational regulatory functions, aligning activities with business outcomes while serving as a subject matter expert for complex regulatory matters.

The Regulatory Affairs Lead will also coach and mentor team members, providing guidance to support their professional development.

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Key Responsibilities
  • Provide expert advice on product registration pathways, regulatory strategies, and business acquisitions to support speed to market and alignment with commercial goals;
  • Identify and mitigate regulatory risks, ensuring compliance with legislation, standards, and corporate procedures while supporting post-market activities and change management;
  • Drive the implementation of new regulatory processes and contribute to continuous improvement initiatives that enhance compliance and operational efficiency;
  • Act as a key escalation point for complex regulatory issues, offering strategic solutions and collaborating across teams to resolve challenges effectively; and
  • Mentor and coach team members, fostering growth and building technical competency to strengthen regulatory expertise across the team.

Must-Have Experience/Skills

  • A minimum of 8 years' experience within a Regulatory Affairs, Quality or similar field and demonstrable success in analysis and interpretation of regulatory documentation and technical writing;
  • Tertiary qualifications in a technical discipline (e.g. Science, Engineering, or related);
  • Strong communication, negotiation, and influencing skills – the ability to quickly build meaningful relationships with internal teams, external stakeholders, and government departments; and
  • A self-driven, strategic thinker who can balance attention to detail and quality, with the ability to thrive in a fast-paced environment and high performance organisation.

Desired But Not Essential Experience/Skills

  • 5+ years of experience in Medical Device regulatory affairs, with a solid understanding of both Australian and international regulatory environments;
  • Strong knowledge of the medical device regulations in Australia and New Zealand. International regulatory knowledge also a plus (e.g. FDA and EU MDR);
  • Experience with Prostheses List management; and
  • Team management experience.

Why Work With Us?

Stryker is a global leader in medical technologies. Together with its customers, it's driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

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