Senior Manager, Regulatory Affairs

Position Summary:

The Senior Manager, Regulatory Affairs provides strategic and operational leadership for global regulatory activities supporting the company’s portfolio of FDA Class II and EU MDR Class IIb medical devices. This position is responsible for developing and executing regulatory strategies to secure and maintain product approvals, registrations, and market access globally, with particular emphasis on international markets.

The Senior Manager serves as a key regulatory partner to product development and cross-functional teams, providing regulatory guidance throughout the product lifecycle, assessing product and manufacturing changes for regulatory impact, and ensuring regulatory requirements are incorporated into development and commercialization strategies. This role also leads the preparation and management of complex regulatory submissions and maintains awareness of evolving global regulatory requirements that may impact the company’s products and business.

Duties & Responsibilities:

• Develop and execute global regulatory strategies for new products, product changes, and lifecycle management activities in alignment with business and product development priorities.
• Lead and manage regulatory submissions, registrations, renewals, and approvals across international markets.
• Prepare, review, and approve regulatory submissions and supporting documentation to ensure accuracy, completeness, scientific validity, and compliance with applicable requirements.
• Serve as the Regulatory Affairs representative on product development and cross-functional project teams, providing strategic guidance throughout the product lifecycle.
• Assess product, design, manufacturing, labeling, and other changes for regulatory impact and determine appropriate regulatory pathways and submission requirements.
• Provide regulatory guidance to R&D, Quality, Clinical, Operations, Marketing, and other cross-functional stakeholders.
• Partner with international distributors, consultants, and regulatory representatives to support registrations and maintain market access in direct and indirect markets.
• Monitor changes to global regulations, guidance documents, and consensus standards, and evaluate potential impact to company products and regulatory strategies.
• Support interactions with regulatory authorities and other external regulatory bodies, including responses to questions and requests for additional information.
• Identify regulatory risks, develop mitigation strategies, and communicate regulatory requirements, timelines, and potential business impacts to key stakeholders and leadership.
• Drive continuous improvement of regulatory processes, procedures, tools, and best practices to support an effective and scalable regulatory function.
• Provide regulatory guidance, mentorship, and subject matter expertise to Regulatory Affairs team members and cross-functional partners.
• Support regulatory inspections, audits, and compliance activities as needed.
• Other duties as needed or required.