Director Global Regulatory Ad/Pro jobs in United States
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Intuitive · 22 hours ago

Director Global Regulatory Ad/Pro

Intuitive is a pioneer and market leader in robotic-assisted surgery, dedicated to enhancing minimally invasive care. The Director of Global Regulatory Advertising and Promotion will lead regulatory compliance activities, manage the advertising and promotion process, and ensure that the organization meets current and future regulatory requirements.

Health CareManufacturingMedical Device
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Manage the full scope of the global A&P process and its supporting personnel, leading the A&P team related to all corporate document review related to marketing, product claims, and intended uses
Act as a primary source of expertise related to A&P materials within the organization, reviewing complex, high-level materials used for product communication or advertising
Create and improve the maturity and compliance of Standard Operating Procedures (SOPs), templates, and forms
Liaise between in-country clinical, marketing teams in the Direct and Indirect QARA groups, Subject Matter Experts and Regulatory Affairs to facilitate completion of regulatory review of A&P. Work closely with the local process owners and business partners to ensure global procedures are followed and appropriate evidence/record is established to support audit readiness
Work closely with other managers and leadership teams to better ascertain how A&P can improve ‘forward looking’ regulatory requirements monitoring and provide inputs to the appropriate processes
Develop relationships necessary to exchange data and information with other intelligence groups across Intuitive such as: GAVE, Market Intelligence, Competitive Intelligence, and others, as the need arises
Ensure that periodic updates are prepared as required by leadership and management forums (i.e. Quality Review Board (QRB), Regulatory Surveillance Operating Committee (RSOC), Management Review, etc.). Compiles and reports process metrics and KPIs related to Veeva tool; provides periodic process timeliness reports to help keep assessment and Implementation activities on-target
Work closely with the global regulatory, clinical and compliance organizations to fully understand applicable standards / regulations and implement processes to ensure Intuitive achieves and maintains compliance
Drive intelligence and communication of emerging regulatory trends related to advertising and promotion and implications to internal stakeholders

Qualification

Regulatory complianceAdvertisingPromotion regulationsBusiness process improvementTeam leadershipRegulatory certificationData managementCross-functional collaborationHandle ambiguityCommunication skillsDetail oriented

Required

Bachelor's degree in quality, regulatory, engineering, Engineering, Computer Science, comparable degree, or equivalent work experience required
Minimum of 12 years of overall business experience required
Minimum of 10 years of experience managing, building. or leading teams required
Minimum 5 years' experience with regulations related to advertising and promotion
Experience developing, managing, and improving business processes required
Experience leading and implementing large scale programs required
Willingness to travel and support regional / local team
Building roadmaps for the implementation of large-scale programs
Data management & analytics, database creation, or information modeling
Collaborating with cross-functional teams including engineering, PMO, regulatory, quality, clinical affairs and others
Detail orientated with expertise reading and interpreting regulations, directives, and standards as they relate to advertising and promotion
Knowledge of Regulatory Policy creation, health authority mandates, law and guidance
Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices
Ability to be effective in complex projects with ambiguity and/or rapid change
Ability to handle multiple tasks and to prioritize and schedule work to meet business needs
Detail oriented with emphasis on accuracy and completeness
Strong written and oral communication skills. Proficiency in written and spoken English and the site's local language(s). Any second language is a plus
Travel Requirement minimum 25%

Preferred

Regulatory certification from RAPS is a plus
Experience speaking to executives and leading business change preferred
Presenting to executives and driving business change

Company

Intuitive

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Intuitive designs and manufactures robotic-assisted surgical systems.

H1B Sponsorship

Intuitive has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (339)
2024 (238)
2023 (181)
2022 (285)
2021 (145)
2020 (138)

Funding

Current Stage
Public Company
Total Funding
$5M
Key Investors
St. Cloud Capital
2003-04-30Post Ipo Equity
2000-06-23IPO
1996-01-01Seed· $5M

Leadership Team

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Gillian Duncan
Senior Vice President, Professional Education & Program Services - Worldwide
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Myriam Curet
Executive Vice President & Chief Medical Officer
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Company data provided by crunchbase