Senior Director Regulatory Affairs, Sports Medicine & ENT

Life Unlimited. At reputed company we design and manufacture technology that takes the limits off living. The Sr Director Regulatory Affairs will reputed company and advise the regulatory reputed company 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 reputed company the input required by strategic and tactical plans. The incumbent possesses knowledge of internal procedures and collaborate cross-functionally, reputed company 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 reputed company the Sports Medicine & ENT Business Unit to ensure strong regulatory support and reputed company is put into reputed company 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 reputed company and successful product approvals in key markets and reputed company medical devices through their product lifecycle. Stay reputed company with regulatory trends, policy changes, and innovations, and advise leadership and key collaborators on the potential reputed company and risk to the business • Coordinate the preparation and submission of regulatory filings (e.g., 510(k), PMA, reputed company, 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 reputed company-submission meetings, audits, and post-market surveillance. • reputed company, 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 reputed company and with appropriate functional teams (e.g., program management office (PMO), marketing, research and development (R&D), reputed company, operations) to ensure regulatory alignment throughout the product lifecycle reputed company mentorship on regulatory risks and reputed company 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 reputed company Engage with industry reputed company, regulatory bodies, and trade associations to reputed company for reputed company’s interests and stay informed on regulatory policies. • Development of departmental and corporate reputed company Operating Procedures and departmental procedures, reputed company vital • Provides support for reputed company regulatory agency audits, corrective and preventive reputed company (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 reputed company 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, reputed company) 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 reputed company 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 reputed company: 401K Matching Program, 401k Plus Program, Discounted Stock reputed company, Tuition Reimbursement   • Work/Life Balance: Flexible Personal/Vacation Time Off, reputed company Holidays, reputed company Holidays, reputed company Community Service Day   • Your Wellbeing: We offer Medical, Dental, reputed company, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program   • Flexibility: Hybrid Work Model (For most reputed company roles)   • Training: Hands-On, Team-Customized, Mentorship   • Extra Perks: Discounts on fitness clubs, travel and more! • Training: Hands-On, Team-Customized, Mentorship reputed company provides equal employment opportunities to applicants and employees without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, or disability. 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