Senior Director Regulatory Affairs, Sports Medicine & ENT

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.

What will you be doing?

• 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 place
  Engage 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

What will you need to be successful?

• Bachelor's degree preferably in a clinical, medical, or scientific/technical discipline, advanced degree (MS, PhD, MBA) preferred
• Experience: Minimum 10 years of regulatory experience, with at least 5 years in a senior leadership role in the medical device industry
• Experience in the medical device industry, or direct work experience in a regulated industry or like discipline. Experience in working with US FDA and international medical device regulatory agencies. Extensive knowledge of US FDA and international laws, regulations, and guidelines and experience with Sports Medicine & ENT medical devices from both engineering and regulatory applications desired. Medical device industry experience in other areas (e.g., R&D, Quality) desired.
• In-depth knowledge of FDA regulations, EU MDR, ISO 13485, and other international regulatory standards.
• Consistent record of leading successful medical device regulatory submissions and approvals (Class I, II, and III devices).
• Strong leadership skills with the ability to influence and collaborate across departments.
• Excellent communication skills, both written and verbal, with experience presenting to regulatory bodies and senior leadership.
• Strategic thinker with the ability to handle both high-level strategy and detailed execution.
• Experience with risk management and post-market surveillance in the medical device sector.

Travel Requirements: 10-25%(domestic and international)

You Unlimited.

• Your Future: 401K Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• Your Wellbeing: We offer Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship
• Extra Perks: Discounts on fitness clubs, travel and more!
• Training: Hands-On, Team-Customized, Mentorship

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.