A company is looking for a Principal Regulatory Affairs Specialist for Digital Health Apps.Key Responsibilities : Develop and implement medical device regulatory strategies for global approvalsPrepare and submit regulatory submissions for Class IIa Digital Health apps and other productsInteract with regulatory agencies, create technical documentation, and support product development teamsRequired Qualifications : Bachelor's degree with 7 years or advanced degree with 5 years of regulatory experience in medical device, biotech, or pharmaceutical industriesExperience with SaMD and Digital Health apps, ISO standards, and medical device software regulationsKnowledge of US, EU, and international medical device regulationsRegulatory Affairs Certification (RAC) or Master's degree is a plusBackground in diabetics is desirable
Principal Regulatory Affairs Specialist
Seeking a Principal Regulatory Affairs Specialist to support the Kindeva business in maintaining regulatory compliance of existing manufactured products for customers on a global basis by:. Managing regulatory compliance activities for Kindeva and existing customer products and registrations as requ...
Regulatory Affairs Specialist
A company is looking for a Regulatory Affairs Specialist. ...
Regulatory Affairs Specialist Los Angeles
To help grow and maintain the regulatory and quality standards, we are seeking a Regulatory Affairs (RA) and Quality Assurance (QA) specialist to provide RA-QA support and leadership to ensure compliance with FDA QSR, ISO 13485, and MDSAP for all SprintRay products as well as implement and maintain ...
Regulatory Affairs Operations Specialist I (on-site)
Regulatory Affairs Operations Specialist I. This new team member will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifi...
Regulatory Affairs Operations Specialist I (on-site)
Regulatory Affairs Operations Specialist I (on-site). Regulatory Affairs Operations Specialist I. This new team member will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring product...
Regulatory Affairs Specialist (remote)
Medical manufacturer is hiring a Regulatory Affairs Specialist on a temporary basis. Previous medical device experience in a Regulatory Affairs capacity . ...
Senior Specialist, Regulatory Affairs, Critical Care
From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including p...
Principal Regulatory Specialist
We are seeking a Principal Regulatory Affairs Specialist to support regulatory strategies and submissions for Class III medical devices. Lead regulatory submissions for Class III devices and maintain regulatory communications. Regulatory Affairs, with experience in Class III medical devices. This ro...
Regulatory Affairs Specialist 3.
The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Position: Sr Regulatory Affairs SpecialistLocation: Sunnyvale, CaliforniaPosition...
Senior Regulatory Affairs Specialist
We are currently seeking a Senior Regulatory Affairs Specialist to drive regulatory strategies and submissions for medical devices. Senior Regulatory Affairs Specialist. Hands-on experience with major regulatory submissions and managing interactions with regulatory agencies. Develop and implement gl...