Job description
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.
The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.
Remote USA
$213,200—$266,500 USD
OUR OPPORTUNITY
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, 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!
For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
Link: https://www.natera.com/notice-of-data-collection-california-residents/
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information:
- BBB announcement on job scams
- FBI Cyber Crime resource page
