Principal Regulatory Affairs Specialist

Capstan Medical

. Support Regulatory activities for Capstan mitral and/or tricuspid valve products .

Posted 11/7/2026full-timeSanta Cruz • California • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs within the medical device industry, focusing on compliance with ISO 13485, 21 CFR 820, and EU MDR standards. Proven ability to manage regulatory submissions and maintain quality systems while supporting cross-functional teams in a fast-paced environment.

Highest-signal resume keywords

Regulatory Affairs ExperienceMedical Device SubmissionsISO 13485 ComplianceQuality Systems ManagementClass III Device Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsQuality Systems StandardsClinical InvestigationsRegulatory Strategy DevelopmentLabeling InterpretationProduct Release ApprovalRegulatory Health Authority CommunicationLifecycle ManagementDesign EvaluationManufacturing Change Assessment

Soft Skills

Team CollaborationProject ManagementMultitaskingPrioritizationEthical Judgment

Industry Keywords

Medical Device IndustryClass III Long-Term ImplantableSoftware Regulatory AffairsRobotics ExperienceRegulatory Health AuthorityQMSEMSRegulatory AuditsProduct Listing InformationGlobal Regulatory Strategies

About the role

Key responsibilities & impact

Support Regulatory activities for Capstan mitral and/or tricuspid valve products
Develop, assess, and implement global and regional strategies for investigational use, commercialization, and lifecycle management
Support, author, compile, and manage submissions to regulatory agencies
Evaluate design, labeling, and manufacturing changes to determine necessary regulatory filings
Support regulatory health authority communications and submission requirements
Maintain annual licenses, registrations, and product listing information
Maintain labeling and interpret current standards into labeling
Support regulatory and quality system requirements, including ISO 13485, 21 CFR 820, and EU MDR
Support regulatory and quality system audits and subject matter experts during audits
Support product release by reviewing and approving product release requests
Support company initiatives related to QMS, EMS, and other regulatory requirements
Provide cross-functional team guidance through product changes and approval
Complete other duties as assigned

Requirements

What you’ll need

Bachelor’s degree in Regulatory Science, Biomedical Engineering, Life Sciences, or a related technical discipline
Minimum 6 years of progressive and successful regulatory affairs experience in the medical device industry
Class III long-term implantable, software, and/or robotics experience preferred
Strong experience supporting submissions for high risk, novel medical devices
Familiarity with relevant medical-device regulatory requirements, Quality Systems standards, and clinical investigations
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Ability to leverage and/or engage others to accomplish projects
Ability to multitask, prioritize, and meet deadlines
Good and ethical judgment within company policies and worldwide regulations

Benefits

Comp & perks

Medical, dental, and vision insurance covered at 100% for you and your family
Flexible time off
Fun, fast-paced, collaborative work environment
Office outings and recreational activities
Access to bicycle trails, hiking, and surfing near the office