Staff Regulatory Affairs Specialist

. Coordinate, prepare, and complete premarket applications to the US FDA, including 510(k), Pre-Sub, and De Novo submissions .

Posted 11/7/2026full-timeRemote • United StatesLead💰 $135,500 - $216,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs for medical devices, including preparation of FDA submissions and CE marking technical files. Proficient in technical writing and cross-functional collaboration to ensure compliance with regulatory standards.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA Submission PreparationTechnical Writing SkillsCross-Functional CollaborationEU MDR/IVDR Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

510(k) SubmissionDe Novo SubmissionTechnical File PreparationRegulatory Strategy DevelopmentChange Control ManagementRisk AssessmentSOP DevelopmentProduct Labeling ReviewConfidentiality MaintenanceRegulatory Compliance

Soft Skills

Influencing Without AuthorityTeamwork SkillsCommunication Skills

Tools & Technologies

Microsoft WordMicrosoft ExcelMicrosoft PowerPoint

Industry Keywords

Medical DeviceIn Vitro Diagnostic DeviceFDACE MarkingNotified BodiesMDSAPRegulatory StandardsTrade Organizations

About the role

Key responsibilities & impact

Coordinate, prepare, and complete premarket applications to the US FDA, including 510(k), Pre-Sub, and De Novo submissions
Act as liaison with FDA regarding product submissions
Assess whether proposed device modifications require a 510(k) application
Prepare non-filing justifications for changes that do not require a 510(k) submission
Coordinate and prepare technical files for European Notified Bodies for CE marking of new and modified products
Provide regulatory leadership and guidance to cross-functional product development teams
Identify and communicate quantified regulatory risks and mitigation approaches
Manage Notification of Change and International Regulatory Affairs assessments for sustaining activities
Develop regulatory strategies for Change Controls and establish Regulatory Requirements
Support global regulatory strategies and collaborate with international regulatory associates
Lead regulatory efforts for new regulations and international standards, including EU MDR/IVDR and MDSAP
Review and approve product labeling, promotional materials, and advertising materials
Coordinate responses to customer product-information requests and questionnaires
Maintain FDA device listings and facility registrations
Develop and maintain SOPs, work instructions, and policies
Represent BD in external trade organizations and support regulatory standards development and compliance activities
Improve the efficiency of current work processes

Requirements

What you’ll need

B.S. degree in a scientific, health sciences or technical discipline required (e.g., engineering, bioengineering, biology, chemistry)
5 years of Regulatory Affairs experience in medical device or in vitro diagnostic device companies
Proficient in technical writing skills and compiling successful submissions for the appropriate audience
Experience maintaining confidentiality in dealing with regulatory and clinical documentation
Experience with cross-functional collaboration and teamwork skills including influencing without authority
Proficient in Microsoft Word, Excel, and PowerPoint

Benefits

Comp & perks

Medical, dental, vision, health savings and flexible spending accounts
Life and disability insurance
Wellness resources
Mental health support and disease management programs
401(k)
Deferred compensation programs
Financial counseling
DailyPay
Educational savings resources
Paid time off
Company holidays
Educational assistance
Parental leave
Adoption assistance
Backup care
Caregiving support
Employee assistance programs
Commuter benefits
Pet insurance
Legal services
Associate discount programs
Bereavement, military, personal, family and medical leave, and jury duty leave
Reward and recognition opportunities
Competitive compensation and benefits programs