Orthofix · 14 hours ago
Senior Regulatory Affairs Specialist
United States
Full-time
Remote
Mid, Senior Level
$97K/yr - $128K/yr
5+ years expOrthofix is a company dedicated to improving people's quality of life through innovative medical technologies. The Senior Regulatory Affairs Specialist will ensure compliance with domestic and international regulatory requirements by preparing necessary submissions and reports, supporting project teams, and developing regulatory strategies for new products.
BiotechnologyHealth CareMedical
Responsibilities
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
Regular attendance required
Qualification
Required
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
Preferred
Science or technical degree
RAC Certification
Experience with ISO 14971
Benefits
Bonus, based on performance
Benefits
Company
Orthofix
Orthofix is a global medical device company.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$160M2024-11-07Post Ipo Debt· $160M
1992-05-01IPO
Leadership Team
Andres Cedron
Chief Legal Officer
Clay Aiena
Chief Information Officer
Recent News
2026-01-21
2025-12-24
MarketScreener
2025-11-04
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