Regulatory Affairs Advisor

Natera

. Represent the regulatory function on designated cross-functional teams .

Posted 10/2/2026full-timeRemote • United StatesSeniorLead💰 $146,100 - $182,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory strategy development and execution for FDA Pharma, IVDR, and IVD systems, with a strong focus on compliance and process improvement. Capable of mentoring teams and delivering regulatory training while managing multiple projects effectively.

Highest-signal resume keywords

Regulatory Strategy DevelopmentFDA Pharma SubmissionsIVDR ComplianceRegulatory Affairs Certification (RAC)Project Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsTechnical DocumentationClassification Requests510(k) Premarket NotificationsInvestigational Device ExemptionsPost-Market SurveillanceData-Driven SolutionsContinuous ImprovementProduct Development ProcessesRegulatory Compliance Review

Soft Skills

Excellent Communication SkillsNegotiation SkillsMentoringCross-Cultural CommunicationChange Management

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPoint

Certifications & Qualifications

Regulatory Affairs Certification (RAC)

Industry Keywords

Medical DevicesLaboratory-Developed Tests (LDTs)In Vitro Diagnostics (IVD)Companion Diagnostics (CDx)PMA ExperienceOrgan Health DiagnosticsWomen's Health DiagnosticsEU Medical Device RegulationsIVD RegulationsFDA Regulations

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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