Regulatory Affairs Lead

Work Flexibility: Hybrid

About the role:

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

This role bridges strategic and operational regulatory functions, aligning activities with business outcomes while serving as a subject matter expert and point of escalation for complex regulatory matters. Additionally, the Regulatory Affairs Lead will coach and mentor team members, providing guidance to support their professional development.

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

R546898