Stryker Sydney, New South Wales, Australia Join or sign in to find your next job Join to apply for the Regulatory Affairs Lead role at Stryker Stryker Sydney, New South Wales, Australia 2 days ago Be among the first 25 applicants Join to apply for the Regulatory Affairs Lead role at Stryker 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. 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. 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, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Seniority level Seniority level Associate Employment type Employment type Full-time Job function Job function Legal Industries Appliances, Electrical, and Electronics Manufacturing, Industrial Machinery Manufacturing, and Medical Equipment Manufacturing Referrals increase your chances of interviewing at Stryker by 2x Get notified about new Regulatory Affairs Specialist jobs in Sydney, New South Wales, Australia . Chatswood, New South Wales, Australia 2 weeks ago North Ryde, New South Wales, Australia 1 week ago Sydney, New South Wales, Australia 2 days ago Sydney, New South Wales, Australia 1 month ago Regulatory Submission Specialist (18-months contract) Sydney, New South Wales, Australia 5 days ago Sydney, New South Wales, Australia 2 weeks ago Sydney, New South Wales, Australia 3 days ago Quality Assurance & Regulatory Affairs Associate Sydney, New South Wales, Australia 5 days ago Senior Policy Regulatory Affairs Officer Sydney, New South Wales, Australia 6 days ago Sydney, New South Wales, Australia 1 day ago Senior Associate – Global Regulatory Affairs & Quality Sydney, New South Wales, Australia 2 weeks ago Risk & Regulatory Advisory - Multiple Opportunities Sydney, New South Wales, Australia 3 weeks ago Regulatory Lead - APAC, Kuiper Global Service Compliance External Affairs Sydney, New South Wales, Australia 3 days ago Sydney, New South Wales, Australia 2 days ago Manager – Regulatory Affairs and Engagement Sydney, New South Wales, Australia 2 weeks ago Regulatory Officer - Registration (Express) Senior Manager – Regulatory Affairs and Engagement Sydney, New South Wales, Australia 2 weeks ago Regulatory Affairs Manager | Rare Disease | SYD Sydney, New South Wales, Australia 6 days ago Regulatory Compliance Director, Australia Sydney, New South Wales, Australia 2 days ago Sydney, New South Wales, Australia 4 days ago Legal Content Lead – Financial Services Regulatory Compliance Sydney, New South Wales, Australia 2 weeks ago Head of Regulatory Governance & Quality Assurance Sydney, New South Wales, Australia 2 days ago Sydney, New South Wales, Australia 2 weeks ago Mascot, New South Wales, Australia 1 month ago Partner, Financial Crime Regulatory Reporting and Screening Sydney, New South Wales, Australia 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. J-18808-Ljbffr
