Senior Regulatory Affairs Specialist

Natera

. Prepare regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in domestic and international clinical markets .

Posted 9/30/2026full-timeRemote • United StatesSenior💰 $83,000 - $103,700 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory submissions for medical devices and in vitro diagnostics, with a strong understanding of U.S. and international regulatory requirements. Proficient in risk assessment, project management, and compliance with Good Laboratory Practices and Quality System Regulations.

Highest-signal resume keywords

Regulatory SubmissionsU.S. Medical Device RegulationsRisk AssessmentProject ManagementGood Laboratory Practices

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Affairs510(k) SubmissionsPMA SubmissionsIDE SubmissionsClinical Protocol ReviewRegulatory ComplianceData AnalysisProduct RegistrationLabeling ReviewRegulatory Strategy Development

Soft Skills

Effective CommunicationOrganizational Skills

Certifications & Qualifications

HIPAA TrainingGeneral Policies and Procedure Compliance Training

Industry Keywords

Medical DevicesIn Vitro DiagnosticsBiologicsPharmaceutical IndustryQuality System RegulationsEuropean Medical Device DirectiveClinical StudiesRegulatory AgenciesProduct DevelopmentClinical Data

About the role

Key responsibilities & impact

Prepare regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in domestic and international clinical markets
Develop, execute, and manage procedures and systems ensuring product development and clinical studies address regulatory requirements and business objectives
Interpret U.S. and international medical device and IVD regulatory requirements
Guide product development teams on regulatory requirements
Develop FDA and other regulatory agency submission strategies
Provide risk assessments and regulatory options
Prepare U.S. submissions including 510(k)s, PMAs and supplements, PDPs, IDEs, Pre-Submissions and supplements
Compile information for ex-U.S. product registration or licensing
Interact and negotiate with U.S. regulatory agencies
Coordinate responses to additional data and information requests from regulatory agencies
Participate in product release document development and review
Review clinical protocols and monitor clinical studies and resulting data analyses
Recommend courses of action based on clinical data and regulatory requirements
Review labels, labeling, and promotional materials for regulatory compliance
Provide regulatory opinions on premarket, export, and labeling requirements
Access PHI occasionally in paper and electronic form to perform the job

Requirements

What you’ll need

Bachelor's degree or equivalent; degree in biological sciences, chemistry, or related science strongly preferred
Minimum 5 years of experience in the device/diagnostic, biologic and/or pharmaceutical industry, preferably in regulatory affairs or equivalent
Current knowledge of U.S. medical device and in vitro diagnostic regulatory requirements
Knowledge of Good Laboratory Practices (GLP) and Quality System Regulations (QSR)
Current knowledge of European Medical Device and IVD Directive requirements and European quality system standards
Effective verbal and written communication skills
Ability to organize work
Project management experience desirable
Must complete HIPAA/PHI privacy, General Policies and Procedure Compliance, and security training within the first 30 days of hire
Must maintain current status on Natera training requirements

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
401k benefits
Commuter benefits
Employee referral program