Regulatory Affairs Lead

Buscojobs; Greater London; On-site; GBP 125,000 - 150,000

Job description

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. NOTE: This role is an 18-month contract role.

Key areas of accountability / responsibility:

• Manage regulatory assessments and provide strategic guidance to key stakeholders such as Marketing, Clinical, and Divisional Regulatory, on product registration pathways, maximizing speed to market opportunities and aligning with business priorities.
• Manage registration applications and variations, including high-risk submissions, ensuring compliance with relevant regulatory bodies such as the TGA and Medsafe.
• Develop and maintain strong relationships with key stakeholders, including the TGA, MedTech industry groups, and other regulatory bodies, to influence and advocate for favorable business outcomes.
• Provide recommendations on regulatory strategies for navigating new regulations, standards, or product changes, considering both commercial and regulatory impacts.
• Ensure regulatory strategies align with the Prescribed List submission cycles by collaborating closely with the Reimbursement team.
• Identify and mitigate regulatory risks related to compliance with legislation, regulation, and corporate procedures, ensuring alignment with business goals.
• Support the implementation of new regulatory processes and contribute to continuous improvement initiatives, enhancing RA compliance and operational efficiency.
• Offer strategic regulatory advice on business acquisitions, ensuring smooth integration with regulatory requirements and industry standards.
• Act as a key point of escalation for complex regulatory issues and provide expert guidance to the team and other business functions.
• Support post-market activities, including the management of International Change Notifications (ICNs), Post Market Surveillance activities, and change management processes, ensuring ongoing compliance.
• Stay informed on regulatory reform and legislative changes, advising the business on strategies to minimize or maximize their impact on Stryker operations.
• Mentor and coach team members to foster professional growth, providing guidance on regulatory challenges and supporting their development into higher levels of technical competency.

Skills & Requirements:

• Minimum 8 years’ experience in a similar Regulatory Affairs role.
• Tertiary education in a technical discipline (e.g., Science, Engineering, Biomedical or related).
• High attention to detail and deadline-oriented.
• Self-driven, strategic thinker with the ability to thrive in a fast-paced and high-growth company.
• Proven experience in Regulatory Affairs with demonstrated success in the analysis and interpretation of regulatory documentation and technical writing.
• Strong knowledge of the Medical Device regulations in Australia and New Zealand. International regulatory knowledge desirable e.g., FDA and EU MDR.
• Strong negotiation and communication skills to effectively build relationships with key stakeholders, industry bodies, and regulatory authorities.