Katalyst Healthcares and Life Sciences
Regulatory Affairs Specialist
Katalyst Healthcares and Life Sciences, South Plainfield, New Jersey, us, 07080
Responsibilities:
Provides administrative support for regulatory affairs managerProvides RA support for change control projects and sustaining activitiesConducts regulatory assessments and determines need for re-registration for proposed device changes, prepares internal documentation for changes not requiring re-registration (FDA, EU, OUS)Supports worldwide product registrations through collaboration with regulatory associates and cross-functional product teamResponds to requests for product information by customers or other businessesbility to carry out the above tasks with minimal supervisionExperience with disposable medical devicesExperience with International registrations and renewal.Requirements
Minimum Bachelor's degree; strongly preferred in science or engineeringMinimum 1-3 years' experience in Regulatory Affairs in the medical device industryDemonstrated customer service, cross-functional collaboration, and teamwork skillsProven ability to manage multiple project deliverables and meet project timelinesEffective written and verbal communication skillsScientific and analytical evaluation skills US FDA medical device regulations, standards, and guidance21 CFR 820 - Quality System Regulation.
Provides administrative support for regulatory affairs managerProvides RA support for change control projects and sustaining activitiesConducts regulatory assessments and determines need for re-registration for proposed device changes, prepares internal documentation for changes not requiring re-registration (FDA, EU, OUS)Supports worldwide product registrations through collaboration with regulatory associates and cross-functional product teamResponds to requests for product information by customers or other businessesbility to carry out the above tasks with minimal supervisionExperience with disposable medical devicesExperience with International registrations and renewal.Requirements
Minimum Bachelor's degree; strongly preferred in science or engineeringMinimum 1-3 years' experience in Regulatory Affairs in the medical device industryDemonstrated customer service, cross-functional collaboration, and teamwork skillsProven ability to manage multiple project deliverables and meet project timelinesEffective written and verbal communication skillsScientific and analytical evaluation skills US FDA medical device regulations, standards, and guidance21 CFR 820 - Quality System Regulation.