Regulatory Affairs Advisor

 

POSITION SUMMARY

Title: Regulatory Advisor - FDA Pharma & IVDR

Natera is a clinical genetic testing company specializing in non-invasive, cell-free DNA (cfDNA) and liquid biopsy testing. The Regulatory Advisor plays a key role in developing and driving regulatory strategy on behalf of the regulatory affairs (RA) team, specifically focusing on FDA Pharma and IVDR initiatives. At Natera, we remember there is a person behind every sample. This role combines strong technical knowledge and an understanding of regulatory requirements (US FDA, CAP/CLIA/NYS, EU, or Japan) to support the approval and registration of products that proactively inform disease management.

You will represent the RA team to internal and external stakeholders through written and verbal communication. This role maintains product registrations, change assessments, post-market surveillance reports, and records of communication with regulatory authorities. You will support the overall effectiveness of the RA team through contributions to staff development, process improvements, and maintaining a deep understanding of current regulatory requirements in the evolving diagnostics landscape.

PRIMARY RESPONSIBILITIES

• 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 in the context of submissions or registrations.

• Build and execute bold, practical regulatory strategies for complex regulatory affairs programs, with a heavy emphasis on FDA Pharma, IVDR, and In Vitro Diagnostic (IVD) systems.

• Advocate for the least burdensome approaches to product clearance and approval while strictly interpreting and 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 critical worldwide registrations.

• Mentor regulatory associates and support their career advancement.

• Deliver training on regulatory topics across internal teams.

• Lead cross-functional teams to address major regulatory changes, compliance with new registration requirements, or process improvements.

• Contribute to setting individual and departmental annual goals aligned with business objectives.

• Review and ensure regulatory compliance of advertising, promotion, and labeling across a common product line.

• Take personal accountability for identifying gaps in processes and proactively build data-driven solutions to improve them.

• Evaluate product changes for global regulatory submission impact.

• May lead small teams.

• Other duties as assigned.

QUALIFICATIONS

• Bachelor’s degree in a life science field (biology, microbiology, chemistry, engineering, medical technology, regulatory science, etc.) or equivalent. Advanced degree in life sciences (MS, PhD, etc.) and/or MBA preferred.

• Regulatory Affairs Certification (RAC) preferred.

• Minimum of 8+ years of direct applicable regulatory experience in medical devices, laboratory-developed tests (LDTs), or pharma.

• Direct experience with FDA Pharma and IVDR submissions is highly preferred.

• Experience in Organ Health or Women's Health diagnostics is ideal and strongly preferred.

• In Vitro Diagnostics (IVD) and Companion Diagnostics (CDx) experience is a plus.

• PMA experience preferred.

KNOWLEDGE, SKILLS, AND ABILITIES

• Working knowledge of U.S. and EU Medical Device/IVD/IVDR, FDA Pharma, and/or laboratory developed test regulatory requirements.

• Proactive, self-directed, and highly engaged.

• Emphasis on talent development and team building.

• Use sound scientific judgment to solve problems and make decisions even when rigid policies do not exist.

• Manage multiple projects with urgency, staying organized and focused on delivering results.

• Demonstrated ability to effectively formulate and drive change.

• Experienced in continuous improvement projects, project management, and product development processes.

• Thrive in ambiguity by navigating rapid change and actively building structure and standard operating procedures where they are missing.

• Excellent written and verbal communication skills, including the ability to communicate across cultures, work effectively with technical and scientific personnel, and negotiate clearly with Regulators.

• Computer literacy (PC, Microsoft Word/Excel/PowerPoint).

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$146,100—$182,600 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