Senior Regulatory Affairs Specialist
Orthofix
full-time
Posted on:
Location Type: Remote
Location: California • United States
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Salary
💰 $97,000 - $128,500 per year
Job Level
About the role
- Ensure domestic and international regulatory submission and reporting activities are completed in a timely manner
- Prepare domestic and international product submission and reports including: U.S. FDA 510(k)s, IDEs, PMAs, annual reports, international product registrations, MDRs, Vigilance Reports and Problem Reports
- Prepare Technical Files
- Prepare and review product labeling
- Prepare correction and removal (recall) reports and coordinate recall related activities
- Provide regulatory affairs support to project teams
- Develop regulatory strategies for new products
- Review design changes and assess regulatory implication relative to the design change
- Provide regulatory support for quality system related changes i.e. ECOs, MCOs, NCMRs, SDRs, etc.
- Help drive process and compliance improvements activities
- Lead health hazard evaluations to determine risk associated with post-market product issues
- Provide regulatory affairs support during external inspections (FDA, BSI, etc.)
- Provide regulatory affairs guidance to other Orthofix departments, as necessary
Requirements
- College degree or equivalent work experience in Regulatory, Quality or R&D
- Minimum of 5 years experience in Regulatory Affairs
- Experience with FDA QSR requirements, ISO 13485, and EU Medical Device Directive regulatory requirements
- Excellent oral and written communication skills
- Public speaking proficiency
- Willing to mentor others
- Ability to prioritize, conduct team meetings, and meet project deadlines
- Nonessential Skills: Science or technical degree, RAC Certification, Experience with ISO 14971
Benefits
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Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionproduct labelingtechnical files preparationregulatory strategies developmentdesign change assessmentquality system changes supporthealth hazard evaluationsprocess improvementcompliance improvementrisk assessment
Soft Skills
oral communicationwritten communicationpublic speakingmentoringprioritizationteam meeting facilitationdeadline management
Certifications
RAC Certification