Global Regulatory Professional
3 days ago
Extremity Care is seeking a highly experienced Regulatory Affairs Manager to lead our global regulatory efforts. As a key member of our team, you will be responsible for ensuring regulatory compliance and managing regulatory submissions.
- Develop and implement regulatory strategies.
- Collaborate with cross-functional teams to achieve regulatory goals.
- Ensure compliance with FDA and Health Canada regulations.
Responsibilities:
- Manage unique device identifiers (UDI) submissions.
- Lead regulatory submissions for various purposes.
- Participate in FDA inspections and maintain records.
Requirements:
- Bachelor's degree in a biological science or related field required.
- At least 5 years of quality and/or regulatory experience in an FDA/MDR regulated environment.
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San Antonio, Texas, United States Extremity Care Full timeJob OverviewAt Extremity Care, we are seeking an experienced Regulatory Affairs Manager to support and manage our global regulatory affairs department. This role is responsible for ensuring compliance with FDA and Health Canada regulations for quality management systems, product realization, and marketing authorization.ResponsibilitiesFoster accurate and...
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