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Stryker

Regulatory Affairs Lead

Reposted Yesterday
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In-Office
Saint Leonards, Victoria
Mid level
In-Office
Saint Leonards, Victoria
Mid level
The Regulatory Affairs Lead oversees regulatory activities, ensuring compliance, providing strategic guidance, mentoring team members, and engaging with stakeholders all to align regulations with business goals.
The summary above was generated by AI
Work Flexibility: Hybrid

About the role:

We are currently looking for a permanent Regulatory Affairs Lead to join the team here at Stryker SSP. The Regulatory Affairs Lead looks after the key regulatory work for Stryker South Pacific, making sure the business meets all relevant regulatory and legislative requirements.

The role balances both big‑picture thinking and day‑to‑day regulatory activities, working closely with the business to support practical outcomes. Acting as a trusted expert, the Regulatory Affairs Lead is the go‑to person for complex regulatory issues and escalations, while also coaching and supporting team members to help them grow and develop in their careers.

About you:

You're a sharp, commercially minded professional with experience navigating complex, highly regulated environments - whether that’s FMCG, Alcohol, Financial Services, Pharma, Life Sciences, or similar. You may not come from a traditional Regulatory Affairs or medical device background, and that’s okay. What matters is your ability to think strategically, influence stakeholders, and solve problems with confidence and care.

You’re ready to step into a role that blends compliance with commercial impact. You’re a natural relationship builder, a persuasive communicator, and a curious learner who thrives in complex, fast-paced environments. You may not have led a team yet, but you’re hungry to grow into leadership—and we’re ready to support that journey.

Key responsibilities

  • Strategic regulatory guidance: Advise on product registration pathways, regulatory strategies, and business acquisitions to accelerate speed to market and align with commercial goals;

  • Risk management and compliance: Identify and mitigate regulatory risks while ensuring compliance with legislation, standards, and internal procedures. Support post-market activities and change management initiatives;

  • Process improvement and implementation: Lead the rollout of new regulatory processes and contribute to continuous improvement efforts that enhance compliance and operational efficiency;

  • Stakeholder engagement and issue resolution: Act as a trusted escalation point for complex regulatory issues. Collaborate cross-functionally to resolve challenges and deliver strategic solutions; and

  • Leadership and team development: Coach and support peers and junior team members, building technical capability and fostering a culture of growth and learning.

Must have experience/skills:

We’re looking for someone with a unique blend of skills and mindset. You’ll thrive here if you have:

  • Exposure to highly regulated industries and a strong understanding of compliance frameworks;

  • Tertiary qualifications in a related discipline;

  • Excellent communication, negotiation, and influencing skills;

  • A strategic mindset with the ability to balance detail and big-picture thinking;

  • A collaborative style and the ability to navigate competing priorities;

  • A passion for continuous improvement and smarter ways of working; and

  • An interest in coaching, mentoring and developing teams with a desire to grow into leadership in future.

Desired but not essential experience/skills:

If you’ve got any of the following, that’s a plus—but not a dealbreaker:

  • Experience in medical device regulatory affairs (Australia, NZ, FDA, EU MDR);

  • Familiarity with Prostheses List management; and

  • Prior team management or mentoring experience.

To join us, click apply now!

Stryker is a global leader in medical technologies and, together with its customers, is 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.

Travel Percentage: None

Top Skills

Business Strategies
Compliance Frameworks
Regulatory Processes

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