Regulatory Affairs Specialist - Electrophysiology (on-site)
$50,700–$101,300 year
On-sitePlymouth, Minnesota, United States
Plymouth, Minnesota, United StatesOn-siteFull Time$50,700–$101,300 yearMid LevelBachelors DegreeLarge
Full TimeMid LevelBachelors DegreeLarge
Job Summary
Supports regulatory submissions and documentation for product market entry in Abbott's Electrophysiology portfolio; assists in preparation of regulatory applications, reviews engineering changes, ensures compliance with FDA and worldwide regulatory requirements, maintains regulatory files, may interface directly with regulatory agencies, and supports product release with license approvals; contributes to quality management and environmental management systems initiatives and ensures regulatory requirements across domestic and international scopes are current.
Required Qualifications
- Bachelor’s Degree or equivalent combination of education and work experience
- Ability to work in a highly matrixed and geographically diverse business environment
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Ability to leverage, manage and/or engage others to accomplish projects
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Strong organizational and follow-up skills, as well as attention to detail and focus towards improving quality
- Multitasks, prioritizes and meets deadlines in timely manner
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.