Principal Regulatory Affairs Specialist

Employer Industry: Medical Device Manufacturing

• Salary up to $
• Eligible for the Medtronic Incentive Plan (MIP) for short‑term incentives
• Comprehensive benefits package, including health, dental, vision insurance, and more
• Opportunities for career advancement and professional development within a global leader in healthcare technology
• Collaborative work environment focused on innovation and patient care
• Flexibility with a hybrid work schedule, working onsite 4 days a week

• Support the development and implementation of regulatory strategies for new and existing products
• Lead submission activities for obtaining required clearances and approvals for medical devices
• Interpret regulatory requirements and ensure compliance for products manufactured by the employer
• Participate as the regulatory representative in new product development teams
• Provide support for acquisitions, including due diligence and post‑acquisition assessments

• Bachelor’s Degree with a minimum of 7 years of relevant experience or an advanced degree with a minimum of 5 years of relevant experience
• 7+ years of medical device experience and work experience in regulatory affairs
• Specialized knowledge in the preparation of 510(k) or PMA submissions for FDA and Technical Files for EU
• Excellent written and oral communication skills
• Strong organizational and multi‑project management skills

• 10+ years of medical device experience and work experience in regulatory affairs
• In-depth knowledge of U.S. and EU regulations and international device regulations
• Understanding of combination products and associated regulations
• Knowledge of Good Manufacturing Practices
• Proficiency in MS Word, Excel, and Power Point

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