Regulatory Expert

5 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $155,000
Regulatory Affairs Lead Role Summary

The Regulatory Affairs Lead is responsible for overseeing and driving key regulatory activities, ensuring compliance with relevant regulations and legislation. This role bridges strategic and operational regulatory functions, aligning activities with business outcomes.

This position requires a strong regulatory professional with significant experience in a similar Regulatory Affairs role, ideally within the healthcare or medical devices industry. The ideal candidate will bring a depth of knowledge and experience working within highly regulated industries, interacting with regulatory authorities, and navigating complex regulatory environments.

About the Job Description:

  • Key Responsibilities: 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 effectively; and

  • Leadership and Team Development: Mentor and coach team members, fostering growth and building technical competency to strengthen regulatory expertise across the team.

Required Skills and Qualifications:

  • 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;

  • 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;

Benefits:

Stryker is a global leader in medical technologies and together with its customers is driven to make healthcare better. We impact more than 150 million patients annually.

Join us by clicking the link below.

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