-
ID
#12330855 -
Job type
Permanent -
Salary
TBD -
Source
Arthrex -
Date
2021-04-16 -
Deadline
2021-06-15
Regulatory Affairs Specialist I
Florida, Naples, 34108 Naples USAPermanent
Vacancy expired!
- Limited use and/or application of technical principles, theories, and concepts.
- Basic knowledge of regulatory framework and regulatory requirements for one region.
- Basic knowledge of human physiology/anatomy and associated medical terminology.
- Basic knowledge of orthopedic terminology, surgery principles, theories and products.
- Basic knowledge of current medical device regulations, standards, guidances and regulatory requirements for medical devices in region of specialization.
- Basic knowledge of 21 CFR 820/ISO 13485.
- Basic knowledge of product lifecycle, product development process, design control and change control.
- Basic knowledge of clinical trial strategy and study design, and sponsor reporting requirements.
- Experience in a regulatory affairs role in the life science industry preferred.
- Bachelors degree preferred, engineering or science discipline preferred.
- Advanced degree preferred.
- Orthopedic medical device experience preferred.
- Regulatory Affairs Certification (RAC) preferred.
- Regulatory submission experience preferred.
Vacancy expired!
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