Senior Regulatory Affairs Specialist
Orthofix(28 days ago)
About this role
A Regulatory Affairs professional at Orthofix supporting the company’s mission to deliver innovative musculoskeletal medical technologies. The role is part of the global Regulatory Affairs team and focuses on enabling product availability across domestic and international markets by aligning with applicable regulatory standards. It operates within a collaborative, values-driven environment working closely with cross-functional partners and healthcare professionals.
Required Skills
- Regulatory Submissions
- Technical Files
- Product Labeling
- Recall Management
- Risk Evaluation
- Post-Market
- FDA QSR
- ISO 13485
- EU MDD
- Communication
+2 more
Qualifications
- College Degree
- Science Degree (Preferred)
- RAC Certification
About Orthofix
orthofix.comOrthofix is a leading medical device company and provider of spinal, orthopedic, bone growth, and motion preservation products since 1980.
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