Director, Advertising and Promotional Material (Hybrid)

Position Overview: 

The Director of Advertising and Promotional Material, Regulatory Affairs is responsible for leading the end-to-end process for the development, review, and approval of all promotional content related to medical devices. This role ensures that all advertising materials are not only strategically aligned with business goals but also fully compliant with global regulatory standards, including FDA and EU MDR. The ideal candidate will be a process-driven leader with deep expertise in regulatory review and cross-functional collaboration.

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 P 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.

 

Education and Experience:

Minimum 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, with at least 5 years in a leadership role.
• Deep knowledge of FDA, EU MDR, and global regulatory requirements for medical device advertising and labeling.
• 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.

Preferred Skills/Competencies: 

• Experience with global regulatory environments (e.g., Canada, LATAM, APAC).
• Familiarity with digital marketing compliance, including social media and influencer content.
• Strong analytical skills and attention to detail in claim substantiation and risk assessment.
• Comfortable working in a matrixed organization with multiple stakeholders.

Travel Requirements:

• Up to 25% domestic and international travel.

NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office. #LI-Hybrid

Additional Information:

The US base salary range for this full-time position is $169,275.00 - $253,912.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipo