Talent.com
Senior Director Regulatory Affairs, Sports Medicine & ENT

Senior Director Regulatory Affairs, Sports Medicine & ENT

Smith+NephewAndover, MA, US
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Sr Director Regulatory Affairs

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 will cross-functionally 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.
  • 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 : 1025% (domestic and international)

    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!

    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.

    serp_jobs.job_alerts.create_a_job

    Director Regulatory • Andover, MA, US

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Oncology Regulatory Affairs Director

    Oncology Regulatory Affairs Director

    VirtualVocationsManchester, New Hampshire, United States
    serp_jobs.job_card.full_time
    A company is looking for an Associate Director, Regulatory Affairs (Oncology).Key Responsibilities Manage regional regulatory activities as part of a Global Regulatory Team Lead regulatory activ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Regulatory Diagnostics Manager / Senior Regulatory Diagnostics Manager

    Regulatory Diagnostics Manager / Senior Regulatory Diagnostics Manager

    Novartis Group CompaniesCambridge, MA, United States
    serp_jobs.job_card.full_time
    The Regulatory Diagnostics Manager (RDM) for Precision Diagnostics is responsible for implementation of strategic plans for development of diagnostics, including companion diagnostics (CDx), as the...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Director, Toxicology Immunology Therapeutic Area

    Director, Toxicology Immunology Therapeutic Area

    Novartis Group CompaniesCambridge, MA, United States
    serp_jobs.job_card.full_time
    This position can be located in the US (Cambridge, MA or East Hanover, NJ) or the United Kingdom (London).The Director Toxicology Immunology Therapeutic Area will provide nonclinical regulatory tox...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Consignment Director, Sports Memorabilia

    Consignment Director, Sports Memorabilia

    VirtualVocationsLowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Consignment Director, Sports / Historical.Key Responsibilities Source high-end collectibles and manage auction placements Evaluate and identify authentic and counterfeit...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Senior Director, Regulatory Affairs

    Senior Director, Regulatory Affairs

    eGenesisCambridge, MA, US
    serp_jobs.job_card.full_time
    Senior Director, Regulatory Affairs.Reporting to the Senior Vice President of Development and based in our Cambridge, MA office, the Director / Senior Director of Regulatory Affairs is responsible fo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Sr. Director, Head of Global Regulatory Labeling Strategy

    Sr. Director, Head of Global Regulatory Labeling Strategy

    ModernaCambridge, MA, US
    serp_jobs.job_card.permanent
    Within an end-to-end (E2E) labeling framework, manage a team of labeling strategy leads responsible for, in partnership with the GRS Strategy team, ensuring the development and implementation of re...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Director of Regulatory Affairs

    Director of Regulatory Affairs

    VirtualVocationsDorchester, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director, Regulatory Affairs, Dx / CDx and Medical Devices.Key Responsibilities Develop and implement regulatory strategies for diagnostics and medical devices to support...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Director, Regulatory CMC

    Senior Director, Regulatory CMC

    PepGenBoston, MA, US
    serp_jobs.job_card.full_time
    PepGen Regulatory CMC Strategy Leader.PepGen is at an exciting time in our development.This role is for a motivated and team-oriented individual who flourishes in an environment where they can help...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    US Regulatory Policy Director

    US Regulatory Policy Director

    VirtualVocationsManchester, New Hampshire, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director, US Regulatory Intelligence & Policy Lead.Key Responsibilities : Lead the acquisition, analysis, communication, and knowledge management of US regulatory in...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Utility Regulatory Director

    Utility Regulatory Director

    VirtualVocationsLowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director, Utility Regulatory Support.Key Responsibilities Act as a steward of regulatory relationships, processes, and deliverables Research and apply findings across ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Senior Director / Director of Regulatory Affairs

    Senior Director / Director of Regulatory Affairs

    Redefine Your Future with TransMedicsAndover, MA, US
    serp_jobs.job_card.full_time
    Senior Director / Director of Regulatory Affairs.TransMedics' pioneering Organ Care System (OCS) was developed to address the major limitations of the current standard of care, cold storage, by prese...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Director, Regulatory Strategy Consulting

    Senior Director, Regulatory Strategy Consulting

    Halloran Consulting GroupBoston, MA, United States
    serp_jobs.job_card.full_time
    Career Opportunities with Halloran Consulting Group.Senior Director, Regulatory Strategy Consulting.Are you looking for a company that is committed to improving human health, and a role that will d...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    South Carolina Licensed Senior Medical Director

    South Carolina Licensed Senior Medical Director

    VirtualVocationsLowell, Massachusetts, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Medical Director to oversee medical review strategies and collaborate with stakeholders. Key Responsibilities Oversee the development and implementation of Medica...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Senior Director Global Regulatory Affairs Global Regulatory Lead Neuroscience

    Senior Director Global Regulatory Affairs Global Regulatory Lead Neuroscience

    Takeda PharmaceuticalsBoston, MA, US
    serp_jobs.job_card.full_time
    At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and oth...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Regulatory Strategy Manager

    Senior Regulatory Strategy Manager

    VirtualVocationsManchester, New Hampshire, United States
    serp_jobs.job_card.full_time
    A company is looking for a Sr Manager Global Regulatory Strategy to oversee clinical trial activities across multiple programs. Key Responsibilities : Serve as the regulatory affairs lead for clini...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
    • serp_jobs.job_card.promoted
    Sr. Director, Regulatory Affairs

    Sr. Director, Regulatory Affairs

    Akebia TherapeuticsCambridge, MA, United States
    serp_jobs.job_card.full_time
    Nearly 37 million Americans are currently affected by Chronic Kidney Disease.At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of e...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Regulatory Affairs Director - Oncology

    Senior Regulatory Affairs Director - Oncology

    AstraZenecaBoston, MA, US
    serp_jobs.job_card.full_time
    Senior Regulatory Affairs Director.Are you a strategically focused Regulatory professional and would like to play an integral part in bringing life-changing Oncology medicines to patients? If you a...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Senior Manager / Associate Director, Regulatory Strategy

    Senior Manager / Associate Director, Regulatory Strategy

    EyePointWatertown, MA, US
    serp_jobs.job_card.full_time
    Be Seen And Heard At Eyepoint Pharmaceuticals.At EyePoint, leadership trusts our employees to get the job done.The patient-centric and award-winning approach we're taking in business fuels our succ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30