Regulatory Affairs Lead

Title:Regulatory Affairs Lead
Location: Saint Leonards Australia

Job Description:

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 an experienced regulatory professional with significant experience in a similar Regulatory Affairs role, ideally within the healthcare or medical devices industry (however this is not essential). You will bring a depth of knowledge and experience working within highly regulated industries, interacting with regulatory authorities and navigating complex regulatory environments. You also have strong leadership, strategic thinking, and technical expertise, with a proactive approach and a proven ability to coach teams and influence stakeholders.

Key responsibilities

• Strategic regulatory guidance: provide expert advice on product registration pathways, regulatory strategies, and business acquisitions to support speed to market and alignment with commercial goals;

• Risk management and compliance: identify and mitigate regulatory risks, ensuring compliance with legislation, standards and corporate procedures while supporting post-market activities and change management;

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

• Stakeholder engagement and issue resolution: act as a key escalation point for complex regulatory issues, offering strategic solutions and collaborating across teams to resolve challenges effectives; and

• Leadership and team development: 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 and growth 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.

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