Not specified; not specified; comprehensive benefi...
7-8 years medical device regulatory experience
Expertise in us eu and tga regulations
Knowledge of iso 13485 and iso 14971 standards
The role involves developing global regulatory strategies for new product development initiatives including hardware and software as a medical device (SaMD)
Job Summary
The role involves developing global regulatory strategies for new product development initiatives including hardware and software as a medical device (SaMD).
Candidates will partner closely with clinical affairs to execute clinical strategies necessary for achieving marketing authorizations in the US, EU, and Australia.
Enovis offers a comprehensive benefits package including medical, dental, vision insurance, 401(k) plans, and various income protection options.
Matching Summary
The role involves developing global regulatory strategies for new product development initiatives including hardware and software as a medical device (SaMD).
Salary
Not specified; Not specified; Comprehensive benefits package including medical, dental, vision, 401(k), and vacation
Skills & Requirements
Must-have
7-8 years medical device regulatory experience
Expertise in US EU and TGA regulations
Knowledge of ISO 13485 and ISO 14971 standards
Experience preparing 510(k) submissions
Ability to manage post market surveillance activities
Nice-to-have
Experience with machine learning and artificial intelligence
International regulatory submission experience
Strong cross-functional collaboration skills
Proven ability to lead pre-submission meetings
Background in orthopedic industry products
Key Requirements
Bachelor's degree in science or biomedical engineering
7-8 years experience in RA within medical devices
Full-time work authorization in the United States without sponsorship
Work Rights
Must have full-time work authorization in the United States