Senior Director, - Regulatory Affairs

Position Summary
The Senior Director, Regulatory Affairs plays a critical leadership role in advancing Natera on a global scale. This individual defines and leads regulatory strategy and collaborates with Laboratory Directors to ensure compliance with CAP, CLIA, and NYS DoH requirements. They will serve as a key liaison with regulatory authorities including the FDA and EU regulators, driving innovative pathways for regulatory approval and compliance.

This leader will also guide the integration of regulatory strategy into product development and quality systems, ensuring alignment with ISO 13485, FDA, and applicable laboratory standards. The role requires strategic thinking, cross-functional leadership, and external advocacy to support the business and regulatory success of Natera’s portfolio.

Primary 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.

Qualifications

• 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.

• RAC certification preferred.

• Experience with IVDR and global clinical trial regulations preferred.

• Minimum of 8 years of management experience preferred.

Knowledge, Skills, and Abilities

• 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.

Physical Demands & Work Environment

• Travel required up to 10%; flexibility needed to meet business demands.

• Duties typically performed in an office environment with extended hours as needed.

• Requires use of standard office equipment and ability to communicate effectively by phone and email.