Senior Director, Regulatory Affairs

Summary

Join Natera as a Senior Director, Regulatory Affairs to lead global regulatory strategy and compliance. You will define and execute regulatory strategies, collaborate with Laboratory Directors, and serve as a key liaison with regulatory authorities like the FDA and EU regulators. Responsibilities include preparing and submitting regulatory documentation, guiding product development, and representing Natera in external collaborations. This leadership role requires strategic thinking, cross-functional collaboration, and team development. You will ensure compliance with CAP, CLIA, NYS DoH, ISO 13485, and FDA standards. The position offers the opportunity to drive innovative regulatory pathways and accelerate time-to-market for Natera's portfolio.

Requirements

• Bachelor’s, Master’s, or PhD in a life sciences field (e.g., biology, chemistry, regulatory science); advanced degree or MBA preferred
• 12+ years of experience in IVDs, medical devices, or laboratory-developed tests, with direct involvement in 510(k), PMA, or next-generation sequencing submissions
• Strong experience with CAP, CLIA, and NYS DoH regulatory requirements
• Deep understanding of U.S. and EU IVD/medical device regulatory requirements
• Familiarity with next-generation sequencing technologies
• Demonstrated leadership in regulatory strategy and team development
• Ability to independently exercise judgment within a dynamic, fast-paced environment
• Strong organizational, project management, and problem-solving skills
• Proven ability to drive cross-functional initiatives and lead change
• Excellent written and verbal communication skills, including experience interfacing with regulatory bodies and internal stakeholders
• Proficient in technical documentation and design control processes
• Computer literacy including Microsoft Office applications

Responsibilities

• Develop and execute effective regulatory strategies in collaboration with cross-functional teams to support submissions for IVD products
• Partner with Laboratory Directors to manage submissions to CAP, CLIA, and NYS DoH
• Lead the preparation and submission of regulatory documentation including 510(k), PMA, IVDR, and global registrations
• Provide leadership in developing technical documentation and submission strategies for EU/IVDR compliance
• Collaborate with executive leadership to establish long-term regulatory objectives and secure necessary resources
• Lead and supervise regulatory review of promotional materials, advertising, and labeling
• Guide product development teams on analytical validation strategies and clinical study designs to ensure global regulatory compliance
• Represent Natera in communications with regulatory authorities, including meetings and written responses
• Drive adoption of least burdensome regulatory approaches and novel strategies to accelerate time-to-market
• Monitor evolving regulatory landscapes and advise leadership on implications and required adaptations
• Represent Natera in external collaborations, consortia, and regulatory policy forums
• Support business development by contributing regulatory insights to partnerships, contracts, and strategic planning
• Lead and develop a high-performing regulatory affairs team, ensuring succession planning and talent development
• Perform other related duties as assigned

Preferred Qualifications

• RAC certification preferred
• Experience with IVDR and global clinical trial regulations preferred
• Minimum of 8 years of management experience preferred

Benefits

• Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
• Natera employees and their immediate families receive free testing in addition to fertility care benefits
• Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more
• We also offer a generous employee referral program!