Opportunity Description
Job Description:
The Sr. Regulatory Specialist is responsible for supporting client product and product development and regulatory activities to commercialize new digital products, including AI technologies.
In this role, the Sr. Regulatory Specialist will provide regulatory input on design and development activities to cross-functional teams, to ensure compliance with the relevant regulatory requirements and interactions with regulatory authorities. Responsibilities: Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices.
Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance.
Assist in SOP development and review in support of next gen product offerings.
Revisit and c...
Full-time
Business Operations Specialists