Regulatory Affairs Specialist-Principal

Baxter International Inc.; Fort Snelling Unorganized Territory (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading company in the medical device sector is seeking a Regulatory Affairs Specialist-Principal to implement regulatory strategies and manage product portfolios. The ideal candidate will have a strong background in regulatory affairs, excellent communication skills, and the ability to lead projects in a dynamic environment. This role offers comprehensive compensation and benefits, making it an excellent opportunity for experienced professionals.

Benefits

Comprehensive compensation and benefits

Medical and dental insurance

Retirement plans

Paid time off

Qualifications

• 5+ years of experience in Regulatory Affairs or related fields, preferably medical devices.
• Experience in people management or project management.
• Ability to oversee multiple projects in a matrix team environment.

Responsibilities

• Implement complex regulatory strategies and maintain marketing authorizations.
• Consult with managers and prepare regulatory documents.
• Lead regulatory activities for specific product portfolios.

Skills

Excellent oral and written communication

Presentation skills

Project management

Education

Bachelor’s degree in pharmacy or related scientific discipline

Master’s or PhD

Job description

Join to apply for the Regulatory Affairs Specialist-Principal role at Baxter International Inc.

Responsible for implementing complex regulatory strategies, obtaining and maintaining marketing authorizations for products, and communicating general regulatory requirements to support licensing of Baxter’s products. Acts as a consultant to managers, compiling and submitting regulatory documents in a timely manner according to regulatory requirements. Prepares, reviews, and approves labeling and SOPs. Assists lower-level team members with complex issues and provides regulatory advice to project teams. Offers guidance and coaching to team members within areas of responsibility. Responds to regulatory authority questions within strict deadlines. Maintains regulatory files in compliance with requirements. Develops and initiates complex regulatory project plans. Manages regulatory activities for specific product portfolios or projects (product owner). Maintains and updates existing regulatory authorizations. Leads or represents Regulatory Affairs in project teams. May review promotional materials for compliance with local regulations. Requires a Bachelor’s degree or equivalent in pharmacy or related scientific discipline; a Master’s or PhD is advantageous. At least 5+ years of experience in RA or related fields (preferably medical devices, pharmaceuticals, CROs, or similar), including experience in people management or project management. Ability to oversee multiple projects in a matrix team environment. Excellent oral and written communication, as well as presentation skills. Applicants must be authorized to work in the U.S. Baxter offers comprehensive compensation and benefits, including medical, dental, insurance, retirement plans, paid time off, and other employee benefits.