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Designation : Regulatory Specialist
Experience : 7+
Location : Pune
Qualifications
- Bachelor of Science in science and/or engineering field
- 8 - 12years of regulatory experience in medical device industry (equivalent industry/educational experience may be considered)
- Thorough working knowledge of applicable FDA, ISO, EU and/or other region-specific medical device regulations, requirements, and standards.
- Experience in Orthopedics industry preferred.
- 510(k) experience and Regulatory Affairs Certification (RAC) preferred.
- Ability to work under limited supervision with FDA, Notified Body, Authorized Representatives, 3rd party license holders and other global regulatory agencies.
- Ability to support and execute activities related to product development teams and cross-functional projects.
- Ability to work well with others and manage projects.
- Excellent written and verbal communication skills. Proficient in Microsoft Office
- Ability to read and speak English sufficiently to read, understand, and complete all documentation.
Mandatory Skills
- Medical Device Regulations,FDA Medical Device Regulations,Regulatory Compliance,Medical Devices,Cross-Functional Teamwork
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