Regulatory Affairs Professional

We are seeking a Regulatory Affairs Professional to join our team at Radiometer, a Danaher operating company. The ideal candidate will have a background in life sciences, diagnostics, and biotechnology, with experience in regulatory affairs, particularly in the medical device industry. The role involves coordinating regulatory activities, providing regulatory input, and ensuring global compliance.

Requirements

• Bachelor's or master's degree in science, engineering, pharmacy, biology, biotechnology, medical technology, or related field
• Over 3 years of experience in the regulated medical device industry for candidates with a master's degree, or 5 years for those with a bachelor's degree
• Experienced in performing global regulatory change assessments to ensure compliance with EU MDR/IVDR, FDA, MDSAP, and country-specific regulations
• Proven ability to lead regulatory strategies across the product lifecycle, including design control, risk assessments, change assessments, and product launches
• Experienced in maintaining regulatory documentation and supporting submissions, including STED files, 510(k)s, global registrations, and communications with notified bodies, FDA and other country-specific competent authorities

Benefits

• Comprehensive, competitive benefit programs
• Health care program
• Paid time off
• Relocation Assistance
• 401k Matching
• Retirement Plan
• Generous Paid Time Off