-
ID
#12660154 -
Job type
Permanent -
Salary
TBD -
Source
Arthrex -
Date
2021-04-26 -
Deadline
2021-06-25
Principal Regulatory Affairs Specialist - EU
Florida, Naples, 34108 Naples USAPermanent
Vacancy expired!
- Develop regulatory strategies and implementation plans for the preparation and submission of new products and review any proposed changes for impact on regulatory strategy and status.
- Applies extensive technical expertise and has full knowledge of other related disciplines.
- Advanced knowledge of regulatory framework and regulatory requirements for multiple regions.
- Novice knowledge of human physiology/anatomy and medical terminology.
- Intermediate knowledge of orthopedic terminology, surgery principles, theories, and products.
- Advanced knowledge of current medical device regulations, standards, guidances and regulatory requirements for medical devices in region of specialization
- Advanced knowledge of 21 CFR 820/ISO 13485.
- Advanced knowledge of product lifecycle, product development process, design control and change control.
- Intermediate knowledge of clinical trial strategy and study design, and sponsor reporting requirements.
- 10 years relevant experience required preferably in a regulatory affairs role in the life science industry.
- Bachelors degree required, engineering or science discipline preferred.
- Advanced degree preferred.
- Orthopedic medical device experience preferred.
- Regulatory Affairs Certification (RAC) preferred.
- Experience authoring and submitting medical device registrations/licenses/submissions applicable to regional area.
- Experience reviewing product labeling and advertising/promotional material for medical devices. advertising/promotional material for medical devices. Clinical or statistical experience preferred.
Vacancy expired!
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