Regulatory Affairs Specialist, IV
Inogen
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $106,551 - $127,861 per year
About the role
- Ensure compliance with global medical device regulations throughout the product lifecycle
- Develop and execute regulatory strategies
- Prepare and submit documentation to regulatory authorities
- Maintain adherence to standards such as FDA, EU MDR, and ISO 13485
- Collaborate with cross-functional teams to support product development, labeling, marketing, and post-market activities
- Monitor regulatory changes and ensure timely implementation of projects
- Interface with regulatory agencies (e.g., FDA, Notified Bodies) and respond to inquiries
- Provide regulatory input to support product labeling and promotional materials
- Lead corrective and preventive action (CAPA) efforts as assigned
- Serve as regulatory lead on product development teams
- Provide regulatory input throughout the product lifecycle, including design controls, to support regulatory submissions
- Assess regulatory impact of product changes and provide guidance to cross-functional teams
- Advice on regulatory requirements during design, development, and commercialization phases
- Assess and document regulatory impacts of design changes, manufacturing changes, etc.
- Support and participate in internal and external audits and regulatory agency inspections
- Complete QMS training activities and provide regulatory expertise to continuous improvement activities
- Support Lean and Kaizen initiatives
- Comply with all company policies and procedures
Requirements
- Bachelor of Science degree
- At least 8 years of regulatory affairs experience in the medical device industry, preferably with mechanical-electrical devices and/or respiratory devices
- Current experience leading multiple successful 510(k) clearances and CE marking is required
- Current experience leading international regulatory registrations
- Experience with digital health and Software as a Medical Device (SaMD)
- Strong understanding of medical device product life cycle and regulatory requirements
- In-depth knowledge of ISO 13485, FDA regulations (including 21 CFR Part 820), and EU MDR
- Knowledge of ISO 14971 risk management for medical devices
- Proficiency in database systems and advanced Microsoft Excel skills for reporting and analysis
- Understanding of continuous improvement principles
Benefits
- health, dental, and vision insurance
- 401(k) plan plus employer contribution and match
- generous paid leaves such as vacation and sick leave
- paid volunteer time
- annual performance bonus incentive plan
- highly competitive and company-sponsored benefits
- wellbeing programs rooted in our strong culture of excellence
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategiesregulatory submissions510(k) clearancesCE markinginternational regulatory registrationsdigital healthSoftware as a Medical Device (SaMD)ISO 13485FDA regulationsISO 14971
Soft Skills
collaborationleadershipcommunicationadvisory skillsproblem-solvingorganizational skillsattention to detailcontinuous improvement
Certifications
Bachelor of Science degree