Senior Regulatory Affairs Specialist-Medical Devices
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Job Title: Senior Regulatory Affairs Specialist-Medical Devices Location: Irvine, CA 92606
Duration: 12 Months
Summary
The Senior Regulatory Affairs Specialist will manage and maintain regulatory approvals and clearances for assigned products, ensuring compliance with global regulations.
Key Responsibilities
Duration: 12 Months
Summary
The Senior Regulatory Affairs Specialist will manage and maintain regulatory approvals and clearances for assigned products, ensuring compliance with global regulations.
Key Responsibilities
- Create and track regulatory submissions, ensuring alignment with global operating plans.
- Provide guidance on OUS regulatory strategies and assess impacts of global regulations.
- Represent the OUS regulatory function in product development and manufacturing teams.
- Advise on registration requirements for new and renewing products, and improve processes based on feedback.
- Perform other duties as assigned by leadership.
- Strong knowledge of global medical device regulations (Class II and III).
- Proficient in Microsoft Office Suite (Word, PowerPoint, Excel).
- Excellent written and verbal communication skills.
- Strong problem-solving and analytical abilities.
- Attention to detail and ability to manage competing priorities in a fast-paced environment.
- Ability to work collaboratively across departments.
- Bachelor's degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry).
- 5-7 years of relevant experience.
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