Lead end-to-end regulatory review and approval of global promotional materials for Insulet's Omnipod medical device platform; manage teams, SOPs, Veeva, and cross-functional compliance.
Responsibilities
Own and manage the global advertising and promotional material lifecycle—from concept development through regulatory review, approval, and post-market monitoring
Establish and maintain robust SOPs and workflows for promotional material creation, review, and approval across all regions
Serve as the process owner for promotional review systems (e.g., Veeva Vault), ensuring timely and compliant execution
Lead continuous improvement initiatives to streamline review cycles and enhance cross-functional collaboration
Lead the formal review and approval process for all promotional materials, ensuring compliance with FDA regulations (21 CFR Part 801, 812), EU MDR Article 7, and other applicable global standards
Chair the cross-functional review body, coordinating input from Regulatory, Legal, Clinical, and Medical Affairs
Maintain documentation and audit readiness for all approved materials, including substantiation of claims and version control
Monitor evolving regulatory guidance and proactively update processes and training to ensure ongoing compliance
Partner with Marketing, Product Management, and Clinical teams to ensure promotional messaging is accurate, evidence-based, and aligned with product labeling and intended use
Provide strategic input during campaign planning to ensure regulatory feasibility and risk mitigation
Oversee the development of promotional assets including digital campaigns, print collateral, social media content, and trade show materials
Lead and mentor a team of regulatory reviewers and marketing professionals involved in promotional content development
Develop and deliver training programs for internal stakeholders on compliant advertising practices and regulatory expectations
Foster a culture of accountability and excellence in promotional compliance
Requirements
Bachelor’s degree in Life Sciences, Marketing, Communications, or related field; advanced degree preferred
10+ years of experience in medical device advertising and promotional review
At least 5 years in a leadership role
Deep knowledge of FDA, EU MDR, and global regulatory requirements for medical device advertising and labeling (including 21 CFR Part 801, 812; EU MDR Article 7)
Proven experience managing promotional review processes and systems (e.g., Veeva Vault)
Strong leadership, communication, and project management skills
Ability to translate complex regulatory requirements into actionable guidance for marketing teams
Experience with global regulatory environments (e.g., Canada, LATAM, APAC) (preferred)
Familiarity with digital marketing compliance, including social media and influencer content (preferred)
Strong analytical skills and attention to detail in claim substantiation and risk assessment (preferred)
Comfortable working in a matrixed organization with multiple stakeholders
Willingness to travel up to 25%
Benefits
Hybrid working arrangements
Up to 25% domestic and international travel (role requirement)
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