Regulatory Affairs Manager, U.S. Advertising and Promotions

Working Location: PENNSYLVANIA, BETHLEHEM; PENNSYLVANIA, CENTER VALLEY 

Workplace Flexibility: Hybrid

 

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling. ​​

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Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

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Our five Core Values empower us to achieve Our Purpose: 

 

Patient Focus, Integrity, Innovation, Impact and Empathy. 

 

Learn more about Life at Olympus.

 

**Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

 

 

Job Description

Manager, Regulatory Affairs U.S. Advertising & Promotion will manage the personnel and processes that involve the review of internal and external advertising, promotional (and non-promotional), communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for materials required for product launches in the United States for all divisions of Olympus. 

Job Duties

• This role ensures compliance with FDA regulations, company policies, and industry guidelines
• Manager will work closely with cross-functional teams to support the development and implementation of regulatory promotional strategies and claims matrices
• Serves as the leader for the team that is the regulatory reviewer on the Medical Legal and Regulatory Review Committee (MLR) for product promotion, labeling, core sales training materials, and other promotional and non-promotional communications, including social media, press releases, and talking points
• Coordinates all aspects of regulatory submissions related to promotional materials
• Ensures regulatory compliance while effectively managing business risks through identifying various strategies for addressing business objectives, advising on risk/benefit towards assisting business’ decisions with a clear understanding of the regulatory framework
• Monitors and interprets FDA regulations and guidelines, including FDA warning and untitled letters, relevant to device promotion and advertising
• Develops and implements regulatory training programs for cross-functional partners
• Provides guidance and feedback to internal Business (e.g., Sales, Medical, Market Access) to ensure that promotional and non-promotional practices align with regulatory guidelines and support business objectives
• Other duties as assigned

Job Qualifications

Required:

• BA or BS in a Science Related Field (Engineering, Bioengineering)
• Minimum of 8 years’ experience in Regulatory Affairs in Medical Device Industry. 
• Supervisory experience is required as this position will manage a small team of RA professionals. 
• Travel: Less than 5%

 

Preferred:

• Highly collaborative with a strong attention to detail, organized, ability to execute, flexible and adaptable, ethical, strong communication skills (verbal, written, etc.), and ability to work across multiple departments.
• Extensive knowledge of medical device regulations.  
• Experience with a medical device quality system.
• Good recordkeeping and attention to detail
• Organizational skills, detail oriented, trustworthy

Why join Oly