Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. The Sr Director Regulatory Affairs will lead and advise the regulatory strategy and operations for the Sports Medicine & ENT BU product portfolio. The Sr Director of Regulatory Affairs will be a strategic partner, providing regulatory mentorship to bring new products to market, expand the global registration footprint for existing products, supporting post-market activities, and ensuring adherence to changing regulatory landscapes. The Sr Director Regulatory Affairs is responsible that global regulatory submissions accurately reflect our medical devices’ design and manufacturing processes throughout the product lifecycle and is responsible for ensuring compliance with global regulatory requirements.
The incumbent exhibits an extensive understanding of the medical device industry and a deep understanding of FDA, EU MDR, and other international regulatory requirements to provide the input required by strategic and tactical plans. The incumbent possesses knowledge of internal procedures and collaborate cross-functionally, within the BU and regional regulatory affairs to drive regulatory processes relative to new product development and will serve as a key advisor on regulatory risks and opportunities.

• Responsible for leading new product development (NPD) and tactical teams within the Sports Medicine & ENT Business Unit to ensure strong regulatory support and oversight is put into place for the release and global distribution of medical devices.
• Responsible for the creation and execution of global regulatory strategies for new product development activities to ensure timely and successful product approvals in key markets and all medical devices through their product lifecycle. Stay current with regulatory trends, policy changes, and innovations, and advise leadership and key collaborators on the potential impact and risk to the business
• Coordinate the preparation and submission of regulatory filings (e.g., 510(k), PMA, De Novo, CE Mark, Technical Files, etc.).
• Ensure compliance with applicable regulatory standards, including ISO 13485, FDA QSR, EU MDR, and country-specific requirements.
• Run interactions with regulatory authorities, including pre-submission meetings, audits, and post-market surveillance.
• Lead, handle, and mentor the Sports Medicine & ENT Regulatory Affairs team, ensuring the development of regulatory talent and strong functional performance Builds effective partnerships with RA teams across franchises and regions and with appropriate functional teams (e.g., program management office (PMO), marketing, research and development (R&D), quality, operations) to ensure regulatory alignment throughout the product lifecycle Provide mentorship on regulatory risks and develop mitigation strategies address regulatory challenges during product development and commercialization, including navigating regulatory roadblocks and handling adverse event reporting.
• Supervise and interpret changes in global regulatory requirements and ensure appropriate responses are in placeEngage with industry groups, regulatory bodies, and trade associations to advocate for the company’s interests and stay informed on regulatory policies.
• Development of departmental and corporate Standard Operating Procedures and departmental procedures, when vital
• Provides support for internal and external regulatory agency audits, corrective and preventive action (CAPA) activities, health hazard evaluations (HHE) and field actions
• Responsible for maintaining compliance in device labelling through the review of advertising and promotional materials
• Assists in the development of project specific and departmental budgets
• Participate in new business development activities such as due diligence, acquisition and integrations, as needed
  Location: Andover, MA