Senior Manager, Regulatory Affairs

Position Summary:

The Senior Manager, Regulatory Affairs provides strategic and operational leadership for global regulatory activities supporting the companys 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 companys 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.

Qualifications

Minimum Requirements & Qualifications:

- Bachelors degree in life sciences, engineering, or a related scientific or technical discipline.

- Minimum of 8-12 years of progressive Regulatory Affairs experience within the medical device industry, including experience supporting Class II or comparable regulated medical devices.

- Demonstrated experience developing and executing regulatory strategies for new product development, product changes, and lifecycle management.

- Strong experience preparing and managing international regulatory approvals, registrations, renewals, amendments, and related post-approval activities.

- Working knowledge of international medical device regulations, standards, guidance documents, and quality system requirements.

- Demonstrated ability to interpret complex regulatory requirements and translate them into practical business and product development strategies.

- Strong technical writing, analytical, problem-solving, organizational, and project management skills.

- Proven ability to lead regulatory activities across multiple projects and priorities while meeting business and regulatory timelines.

- Strong communication and interpersonal skills with the ability to influence and collaborate effectively across technical, clinical, quality, operational, and commercial functions.

Preferred Qualifications:

- Advanced degree in life sciences, engineering, regulatory affairs, or a related discipline.

- Regulatory Affairs Certification (RAC) or equivalent professional certification.

- Experience with energy-based, electromechanical, laser, RF, ultrasound, or other complex medical devices.

- Experience providing technical leadership, mentoring regulatory professionals, or leading regulatory projects and programs.

- Experience interacting directly with FDA and international regulatory authorities.

- Experience developing and executing regulatory strategies to secure market access in LATAM, APAC, and MEA.