[ operations ]
Senior Regulatory Affairs Specialist
ŌURA- Location
- Remote
- Work mode
- Remote
- Type
- full time
- Listed
Applications go directly to ŌURA. Ramai takes no fee for placement and no money for ranking.
[ About this role ]
Senior Regulatory Affairs Specialist at Oura, focusing on Software as a Medical Device (SaMD). This role involves leading regulatory strategy, supporting submissions, managing documentation, and ensuring compliance across the product lifecycle for wellness and regulated features.
Skills and focus areas
- regulatory affairs
- medical device
- digital health
- software as a medical device (samd)
- regulatory strategy
- regulatory operations
- submission support
- document management
- change assessment
- registrations
- regulatory intelligence
- inspection readiness
Summary written by Ramai from the original posting. Full details and requirements are on ŌURA’s careers page.
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