Regulatory Affairs Advisor

Job Description:

• Represent the regulatory function on designated cross-functional teams
• Conduct business interactions with customers and regulatory authorities regarding regulatory pathways, performance claims, supporting data, and labeling for submissions or registrations
• Build and execute regulatory strategies for complex programs, especially FDA Pharma, IVDR, and IVD systems
• Advocate for least burdensome product clearance and approval approaches while adhering to regulatory requirements
• Coordinate and prepare regulatory submissions with minimal supervision, including EU/IVD/IVDR Technical Documentation, classification requests, pre-submissions, 510(k) premarket notifications, investigational device exemptions, NYS DoH submissions, and worldwide registrations
• Mentor regulatory associates and support career advancement
• Deliver regulatory training across internal teams
• Lead cross-functional teams addressing regulatory changes, new registration requirements, and process improvements
• Contribute to individual and departmental annual goals aligned with business objectives
• Review regulatory compliance of advertising, promotion, and labeling across a common product line
• Identify process gaps and build data-driven solutions to improve them
• Evaluate product changes for global regulatory submission impact
• May lead small teams
• Maintain product registrations, change assessments, post-market surveillance reports, and regulatory-authority communication records

Requirements:

• Bachelor’s degree in a life science field or equivalent
• Minimum of 8+ years of direct applicable regulatory experience in medical devices, laboratory-developed tests (LDTs), or pharma
• Working knowledge of U.S. and EU Medical Device/IVD/IVDR, FDA Pharma, and/or laboratory-developed test regulatory requirements
• Experience in continuous improvement projects, project management, and product development processes
• Computer literacy, including Microsoft Word, Excel, and PowerPoint
• Ability to manage multiple projects and deliver results
• Ability to formulate and drive change
• Excellent written and verbal communication skills, including communication across cultures and negotiation with regulators
• Advanced degree in life sciences and/or MBA preferred
• Regulatory Affairs Certification (RAC) preferred
• Direct experience with FDA Pharma and IVDR submissions highly preferred
• Experience in Organ Health or Women's Health diagnostics ideal and strongly preferred
• In Vitro Diagnostics (IVD) and Companion Diagnostics (CDx) experience is a plus
• PMA experience preferred

Benefits:

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Free testing for employees and their immediate families
• Fertility care benefits
• Pregnancy and baby bonding leave
• 401(k) benefits
• Commuter benefits
• Employee referral program