Senior Regulatory Affairs Program Lead

Senior Regulatory Affairs Program Lead

The Senior Regulatory Affairs Program Lead is responsible for developing and executing global regulatory strategies to support the approval and lifecycle management of medical devices. This role provides strategic regulatory leadership, partners with cross functional teams, and ensures compliance across global markets.

Responsibilities

• Lead and coordinate complex regulatory submissions and approval activities with global regulatory agencies.
• Develop regulatory strategies to support new product development, product changes, and ongoing market approvals.
• Provide regulatory guidance to cross functional teams throughout design, development, commercialisation, and post market activities.
• Oversee the preparation, review, submission, and maintenance of regulatory files including 510(k)s, IDEs, PMAs, HDEs, annual reports, technical documentation, and change notifications.
• Support regulatory activities for Class II and Class III medical devices across US and European markets.
• Interact directly with regulatory authorities to facilitate approvals and resolve regulatory issues.
• Review and approve labelling, packaging, advertising, and promotional materials for regulatory compliance.
• Ensure adherence to regulatory procedures, quality requirements, and submission timelines.
• Provide leadership, coaching, and mentoring to regulatory professionals.
• Prepare and review regulatory reports, presentations, summaries, and status updates.
• Partner with stakeholders across R&D, Clinical Affairs, Medical Affairs, Supply Chain, and other functions to achieve business objectives.
• Monitor regulatory developments and assess their impact on products and business strategy.
• Support organisational decision making through regulatory expertise and risk based recommendations.

Requirements

• Bachelor's degree with at least 5 years of relevant experience, or an advanced degree with equivalent experience.
• Practical experience within a medical device regulatory affairs environment.
• Demonstrated experience preparing regulatory submissions for Class II and Class III medical devices in the US and Europe.
• Strong understanding of global medical device regulations and regulatory pathways.
• Ability to develop and execute both strategic and tactical regulatory plans.
• Experience supporting product development and lifecycle management activities.
• Strong stakeholder management and influencing skills.
• Excellent communication, leadership, and collaboration abilities.
• Ability to work independently in a fast paced, deadline driven environment.
• Experience mentoring, coaching, or leading regulatory professionals.
• Strong scientific and technical understanding of medical devices and related regulations.
• Ability to anticipate regulatory changes and assess business impact.