Senior Manager, Regulatory Affairs - Advertising & Promotion

Position Summary:

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Senior Manager of Regulatory Affairs Advertising and Promotion.  The Senior Manager, Regulatory Affairs - Advertising and Promotional will lead a global advertising and promotional group within Arthrex’s Regulatory Affairs organization and will be responsible for the policies and procedures of the Regulatory Advisory Team in support of the Regulatory Affairs department.  This position will develop, manage, and execute global advertising and promotional strategy working in close collaboration with cross-functional teams across the organization to enable the development of creative and compliant materials.  This position is based out of the Arthrex headquarters in Naples, Florida. Relocation assistance may be available along with Arthrex’s exceptional employee benefits and work culture.  Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better™.

We would like this position to sit with us in our Corporate Headquarters in Naples to work directly with the team with a partial-flexible WFH policy in effect.  Generous relocation package offered!  However, this could be a remote position in the USA for the right person.

Duties and Responsibilities:

• Directs and provides regulatory review and approval of advertising and promotional materials, new campaigns and launch strategies. Assures timely and accurate review of advertising and promotional material to meet internal timelines and requirements.
• Oversees and implements innovative regulatory strategies and solutions for all advertising and promotional materials that achieves company objectives while ensuring compliance with regulatory requirements.
• Oversees and ensures advertising and promotional materials are consistent with FTC guidelines and applicable FDA regulations and guidance.
• Monitors web-based and social media material to ensure alignment with regulatory requirements.
• Manages FDA correspondence related to untitled letters, enforcement actions, etc., to analyze and assess impact on company products and communicates risk to department leadership.
• Continually assesses advertising and promotion related processes and procedures to identify opportunity for enhance efficiencies and compliance and partnering cross-functionally to implement update, enhance, and create of internal policies and procedures.
• Provides regulatory advice, risk assessment and mitigation strategies to Product Management and Marketing teams from the early phases of new collateral planning through the development of finalized materials for all advertising and promotional materials.
• Represents Regulatory Affairs in ongoing dialogue with the Arthrex Legal, Corporate Compliance, Medical Affairs, and Quality departments to facilitate an exchange of ideas and to stay current with the standards of all applicable local, state and federal laws, regulations and guidelines governing clinical advisory standards.
• Provides ongoing training on regulation, laws, and guidelines applicable to the company’s ad/promo material to the Product Management, Marketing and Medical Affairs teams.
• Keeps abreast of new or revised regulations, guidelines, points to consider, compliance guides related to ad/promo materials.

Requirements:

• Bachelor’s Degree required; emphasis in health/science-related field preferred.
• Advanced Degree (MS, ME, JD, MBA) preferred.
• 7 years’ experience in a Regulatory Affairs or Legal role required.
• Experience in providing strategic advice on legal and/or regulatory matters pertaining to marketing collateral required.
• Experience in people, project or process management required.
• Experience in reviewing and approving product labels and promotional/advertising materials required.
• Experience in medical device industry required.
• Experience in orthopedic medical device industry preferred.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.