Senior Regulatory Specialist

Evergen (Formerly RTI Surgical)

. Lead regulatory support to product development teams .

Posted 10/20/2026full-timeRemote • United StatesSenior💰 $100,000 - $115,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory support for product development, including preparation of regulatory opinion documents and coordination of labeling activities. Proficient in maintaining compliance with FDA, EU, and other regulatory body regulations while fostering effective relationships with stakeholders.

Highest-signal resume keywords

Regulatory Affairs Certification (RAC)6+ Years Regulatory Specialist ExperienceKnowledge of FDA and EU RegulationsTechnical WritingMicrosoft Office Suite

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory SupportLabeling CoordinationDesign Control Documentation ReviewRisk Management ReportingTechnical Protocols ReviewMetrics Tracking and ReportingImpact AssessmentsAuditing SupportProduct Development Outputs ReviewPromotional Material Development

Soft Skills

Excellent Verbal CommunicationExcellent Written CommunicationRelationship Building

Certifications & Qualifications

Regulatory Affairs Certification (RAC)AATB CTBS

Industry Keywords

Medical DevicePharmaceuticalRegulatory ComplianceGlobal Regulatory AwarenessQuality ObjectivesBusiness Objectives

About the role

Key responsibilities & impact

Lead regulatory support to product development teams
Prepare regulatory opinion documents
Coordinate labeling activities
Review and approve design control documentation, risk management reports, technical protocols and reports, and other product development outputs
Develop, review, and approve labeling, advertising, and promotional material for consistency with approved claims and regulatory requirements
Maintain awareness of global regulatory and product changes and lead impact assessments
Maintain assigned metrics, including preparing, tracking, and trending reports
Support audits and provide timely feedback to stakeholders
Develop and maintain effective relationships with internal and external stakeholders
Support company and departmental quality and business objectives and initiatives
Report on assigned project metrics
Perform other duties as assigned

Requirements

What you’ll need

Bachelor’s degree
6+ years of experience as a regulatory specialist in a relevant medical device or pharmaceutical field
Knowledge of FDA, EU, and other regulatory body regulations
Regulatory Affairs Certification (RAC) preferred
AATB CTBS preferred
Excellent verbal and written communication
Microsoft Office Suite
Technical writing
Ability to move or lift objects up to 25 pounds
Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
Frequent (>75%) fine manipulation using hands and fingers

Benefits

Comp & perks

Annual bonus opportunity up to $10,000
Paid Time Off (PTO)
401(k) match
Holiday pay
Medical, dental, and vision insurance
Short-term and long-term disability coverage
Paid parental leave
Remote work
Home office environment with minimum distractions