Senior Manager, Regulatory Affairs (MedTech)
Core
Senior individual contributor responsible for regulatory decision making and strategy for complex or high-risk products, regions, or regulatory topics.
Role type
Senior Manager, Regulatory Affairs (MedTech)
Builds
Regulatory strategies and compliance for product lines, projects, and regions
Domain
MedTech / Healthcare Regulatory Affairs
Required skills
Regulatory strategy, lifecycle compliance, submission preparation (510(k)/NDA), agency interaction, post-market surveillance, labeling review, mentoring
Preferred skills
Infusion systems, transfusion technologies, cellular therapies, drug regulatory requirements
Technologies
510(k), NDA Supplements, PADERs, PSURs, PMS/PMCF reports
Responsibilities
Own regulatory decision-making and strategy for assigned product lines; Prepare and oversee complex regulatory submissions; Approve strategies developed by Managers and below; Represent Regulatory as senior lead on cross-functional teams; Monitor evolving regulatory requirements; Review and approve product labeling and advertising; Lead Health Authority interactions; Mentor and train regulatory team members
Seniority
Senior Manager, hands-on IC with strategic oversight