Sr. Manager, Regulatory Affairs

Company: Intuitive
Location: Sunnyvale
Posted on: March 30, 2025

Job Description:

Job DescriptionPrimary Function of PositionAs Senior Manager, Regulatory Affairs, you will lead and manage a team responsible for developing and executing regulatory strategies within the Multiport Business Unit. Your role includes ensuring compliance with global regulations for product lifecycle management while mentoring and retaining regulatory professionals to foster a high-performance team. You will collaborate with senior leadership to align regulatory efforts with business goals and drive improvements in regulatory processes to support Intuitive's innovation.Essential Job Duties

• Lead and manage the regulatory affairs team within the Multiport Business Unit, providing strategic and technical guidance to ensure compliance with global regulatory requirements.
• Develop and execute regulatory strategies for new product introductions and modifications, overseeing submissions for the U.S., Canadian, and international markets.
• Act as the primary liaison between regulatory bodies and the company, facilitating communication to expedite submission reviews and approvals.
• Evaluate and interpret new regulations and guidelines, advising senior leadership on potential impacts and necessary compliance actions.
• Coordinate and lead the preparation of regulatory submissions, including 510(k) premarket notifications, Pre-subs, and Canadian license applications.
• Provide regulatory expertise during product development and design control, ensuring that documentation such as risk management and test reports meet regulatory standards.
• Mentor and develop regulatory affairs staff, fostering a culture of continuous improvement and professional growth within the team.
• Collaborate with cross-functional teams, including R&D, quality, and manufacturing, to align regulatory strategies with business objectives and facilitate successful project execution.
• Identify and mitigate regulatory risks, developing contingency plans to address potential compliance issues.
• Stay abreast of industry trends and regulatory changes, integrating new knowledge into strategic planning and operational practices.
• Perform other duties as required, contributing to the overall success of the regulatory affairs function.We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. Actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.Base Salary Range Region 1: $176,000 USD - $264,000 USDBase Salary Range Region 2: $149,600 USD - $187,000 USDShift: DayWorkplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.
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Keywords: Intuitive, Sunnyvale , Sr. Manager, Regulatory Affairs, Executive , Sunnyvale, California