Talent.com
Senior Director, Regulatory Affairs

Senior Director, Regulatory Affairs

StrykerWashington, DC, United States
5 days ago
Job type
  • Full-time
Job description

Senior Director, Regulatory Affairs

Strategic leader responsible for developing regulatory strategy for the Endoscopy business unit, delivering best‑in‑class visualization and connectivity products to market in the United States, Canada and Europe. Works closely with business unit leadership, Marketing, R&D, Clinical and Quality teams to advise on product positioning, entry and exit strategies.

Key Areas of Responsibility

  • Ensure divisional achievement of quality, regulatory, and compliance targets.
  • Direct activities to ensure new product development and product sustainment meet regulatory requirements.
  • Develop, lead, and execute regulatory strategy aligned with business needs.
  • Lead selection, supervision, development, and objective‑setting for team members.
  • Establish best practices to ensure compliance and drive revenue through improved customer experience.
  • Provide a platform for process improvement.
  • Serve as alternate Management Representative when required.
  • Define targets, KPIs, performance objectives for the team and manage direct reports to meet or exceed these targets.
  • Recruit, select, and onboard top talent.
  • Develop team talent to increase performance.
  • Address performance issues proactively and maintain high team engagement.
  • Lead advocacy activities of a more advanced and global strategic nature.

Education / Work Experience

  • BS in Engineering or other relevant field of study.
  • Minimum 10 years’ experience.
  • Master's Degree or equivalent preferred.
  • RAC desired.
  • Knowledge / Competencies

  • Demonstrated knowledge of regulatory requirements, including ISO, FDA, and international requirements.
  • Demonstrated expertise in regulatory systems in a regulated environment.
  • Ability to manage complex projects.
  • Strong verbal, written, and interpersonal communication skills.
  • Teamwork and effective collaboration with cross‑functional management.
  • Ability to manage a multi‑discipline, multi‑technology, team‑based organization with responsibility for quality, regulatory, and compliance targets.
  • Initiative and analytical decision‑making.
  • Experience with recruiting and people development.
  • Influence across the organization.
  • Salary range : $171,500 - $379,000, plus bonus and short‑term and long‑term financial incentives.

    Benefits include medical, prescription drug, dental, vision, critical illness, accident, hospital indemnity, personalized healthcare support, wellbeing and tobacco cessation programs. Financial benefits include HSA, FSAs, 401(k), ESPP, life and disability insurance.

    Applications are accepted for a minimum of 3 days.

    #J-18808-Ljbffr

    Create a job alert for this search

    Director Regulatory • Washington, DC, United States

    Related jobs
    • Promoted
    Senior Manager, U.S. Federal Regulatory Affairs

    Senior Manager, U.S. Federal Regulatory Affairs

    NetflixWashington, DC, US
    Full-time
    Washington DC, District of Columbia, United States of America.Netflix is one of the worlds leading entertainment services, with over 300 million paid memberships in over 190 countries enjoying TV s...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Director of Government Relations and Regulatory Affairs

    Senior Director of Government Relations and Regulatory Affairs

    Tennessee Society of Association ExecutivesWashington, DC, United States
    Full-time
    The Senior Director of Government Relations and Regulatory Affairs serves as CMI’s chief federal lobbyist and regulatory affairs lead, representing the metal can industry before Congress, federal a...Show moreLast updated: 30+ days ago
    • Promoted
    Regulatory Affairs Director, Digital Projects

    Regulatory Affairs Director, Digital Projects

    AstraZenecaGaithersburg, MD, US
    Full-time
    Regulatory Affairs Director Digital Projects.Do you have knowledge in Regulatory Affairs Strategy and Policy, underpinned with experience in Digital Strategy development and digital project leaders...Show moreLast updated: 2 days ago
    Senior Director, GRA Global Regulatory Policy & Strategy - Neuroscience

    Senior Director, GRA Global Regulatory Policy & Strategy - Neuroscience

    Eli LillyWashington Dc Brm, DC, US
    Full-time
    At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work...Show moreLast updated: 1 day ago
    • Promoted
    Regulatory Affairs Director (US)

    Regulatory Affairs Director (US)

    South Dakota StaffingWashington, DC, US
    Full-time
    Director of Regulatory Advocacy.As we create a colorful, capable and cleaner world through chemistry, we invite you to join our team to harness the power of chemistry to shape markets, redefine ind...Show moreLast updated: 1 day ago
    • Promoted
    Regulatory Affairs Director (US)

    Regulatory Affairs Director (US)

    Maine StaffingWashington, DC, US
    Full-time
    Director Of Regulatory Advocacy.As we create a colorful, capable and cleaner world through chemistry, we invite you to join our team to harness the power of chemistry to shape markets, redefine ind...Show moreLast updated: 1 day ago
    • Promoted
    Director, Global Regulatory Affairs, Vaccines (Development and Life Cycle Management)

    Director, Global Regulatory Affairs, Vaccines (Development and Life Cycle Management)

    GSKRockville, MD, US
    Full-time
    Ensure the development of appropriate regulatory strategies and their execution for assigned Vaccines asset(s) consistent with Medicines Development Strategy. This goal has to be achieved both as a ...Show moreLast updated: 30+ days ago
    • Promoted
    Regulatory Affairs Director

    Regulatory Affairs Director

    AstraZenecaGaithersburg, MD, US
    Full-time
    Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines?.At AstraZeneca, ...Show moreLast updated: 6 days ago
    • Promoted
    Senior Director of Government Relations and Regulatory Affairs

    Senior Director of Government Relations and Regulatory Affairs

    KENTUCKY SOCIETY OF ASSOCIATION EXECUTIVES INCWashington, DC, United States
    Full-time
    The Senior Director of Government Relations and Regulatory Affairs serves as CMI’s chief federal lobbyist and regulatory affairs lead, representing the metal can industry before Congress, federal a...Show moreLast updated: 30+ days ago
    • Promoted
    CMC Mature Products Regulatory Senior Manager

    CMC Mature Products Regulatory Senior Manager

    Kappaalphapsi1911Rockville, MD, United States
    Full-time
    This role offers an exciting opportunity to lead and deliver Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for vaccines. You will manage global CMC regulatory activities across ...Show moreLast updated: 3 days ago
    • Promoted
    CMC Mature Products Regulatory Senior Manager

    CMC Mature Products Regulatory Senior Manager

    GlaxoSmithKlineRockville, MD, United States
    Full-time
    This role offers an exciting opportunity to lead and deliver Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for vaccines. You will manage global CMC regulatory activities across ...Show moreLast updated: 10 days ago
    • Promoted
    Senior Manager, Regulatory Affairs

    Senior Manager, Regulatory Affairs

    EuclidSterling, VA, US
    Full-time
    Senior Manager, Regulatory Affairs.Shape the Future of Vision Care with Euclid Vision Corporation!.Are you a regulatory affairs professional with a passion for medical device innovation? Do you thr...Show moreLast updated: 20 days ago
    • Promoted
    Senior Director, Regulatory Affairs (Office or Remote)

    Senior Director, Regulatory Affairs (Office or Remote)

    Arcus BiosciencesWashington, DC, US
    Remote
    Full-time
    Senior Director Of Regulatory Affairs.The Senior Director of Regulatory Affairs provides regulatory leadership and develops regulatory strategies for products in development to support clinical tri...Show moreLast updated: 22 days ago
    • Promoted
    Associate Director, Regulatory Affairs

    Associate Director, Regulatory Affairs

    Wave Life SciencesWashington, DC, US
    Full-time
    Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, ch...Show moreLast updated: 30+ days ago
    • Promoted
    Director, Regulatory Science and Policy

    Director, Regulatory Science and Policy

    American Association for Cancer ResearchWashington, DC, US
    Full-time
    Director, Regulatory Science And Policy.The Director, Regulatory Science and Policy, works closely with the Vice President, Science Policy and Government Affairs (and Chief Policy Officer) to imple...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Director, Pharma Policy and Advocacy Counsel

    Senior Director, Pharma Policy and Advocacy Counsel

    Larson MaddoxWashington, DC, US
    Full-time
    Our client is a leading Pharmaceutical Advocacy and Research Organization committed to advancing public health through innovation, advocacy, and collaboration. Its members include top pharmaceutical...Show moreLast updated: 30+ days ago
    • Promoted
    Sr. Director, Aviation Regulatory Engineering

    Sr. Director, Aviation Regulatory Engineering

    Maryland StaffingGermantown, MD, US
    Full-time
    Director, Aviation Regulatory Engineering.EchoStar is reimagining the future of connectivity.Our business reach spans satellite television service, live-streaming and on-demand programming, smart h...Show moreLast updated: 1 day ago
    • Promoted
    Senior Regulatory Affairs Manager

    Senior Regulatory Affairs Manager

    Katalyst Healthcares & Life SciencesColumbia, MD, US
    Full-time
    Responsibilities : Support the Senior Director in developing and executing regional regulatory strategies for QOL initiatives within specific regions. Contribute to providing strategic oversight and ...Show moreLast updated: 13 days ago