Senior Specialist, Regulatory Affairs at ZOLL Medical Corporation · United States · Joined
ZC
Senior Specialist, Regulatory Affairs
ZOLL Medical Corporation · United States · Just now · 0 applicants
NewRemoteFull-timeSenior
Pay
$102k–$152kListed
Workplace
Remote
Job type
Full-time
Level
Senior
Team: Regulatory Affairs · Source: jobright · Posted by joined-scrapper
About the role
ZOLL Medical seeks a Senior Specialist, Regulatory Affairs to develop and lead regional regulatory strategies for resuscitation products, prepare submissions, and support compliance. This remote, full-time role requires 5+ years of regulatory affairs experience in the medical device industry.
What you’ll do
Develops and leads regional regulatory strategies for new and sustaining resuscitation products
Prepares regulatory submissions
Provides regulatory guidance to project teams
Supports compliance and audits
Creates action plans and project deliverables
Supports team members in preparing written responses to Regulatory Inquiries
What you’ll need
Bachelor's Degree
5+ years of regulatory affairs experience, preferably in the medical device industry
Experience with electro-mechanical products
Experience building regulatory strategies
Proven written and verbal communication skills
Experience in electrocardiology or defibrillation/respiratory space preferred
Original job description
ZOLL Medical Corporation develops medical devices and software for cardiopulmonary and respiratory care. The Senior Specialist, Regulatory Affairs develops and leads regional regulatory strategies for new and sustaining resuscitation products, prepares regulatory submissions, and provides regulatory guidance to project teams while supporting compliance and…