Regulatory Affairs Specialist I
Company Name:-
Freudenberg Medical
Job Location:-
Carpinteria, CA 93013
Job Summary:-
Careers that make a difference! Freudenberg Medical designs and manufactures medical devices and components for clients worldwide.
We are focused on innovative processing technologies, lean manufacturing, waste reduction, and high quality product solutions for our Fortune 100 medical device customers.
Join our fast growing team with 11 manufacturing operations around the world.
The Regulatory Affairs Specialist assists with domestic and international regulatory submissions and product registrations.
Ensures regulatory compliance of the complaint system for the market-released products.
Prepares and presents results of data analysis and metrics of the Freudenberg Quality System related to complaints.
Ready to make a difference?
(NOT open for Agency Placements)
Regulatory Affairs Specialist I
This position can be remote anywhere in the United States.
Will require the ability and willingness to travel to Carpinteria, CA
Your tasks
Coordinates, assembles, and completes regulatory submissions (both international and domestic) for obtaining device marketing authorizations.
Maintains regulatory files including submissions, EU technical documentation, etc.
Management of domestic and international Standards, directives, regulations, etc.
for gap/impact analysis according to the latest revision.
This includes implementation of procedural and/or documentation updates when necessary.
Assists in regulatory body (including EU Notified Body and FDA), internal, & customer audits, product recalls, Vigilance, adverse event reporting, as necessary.
Performs in-depth review of regulatory data/information and provide oversight of query resolution and data to Supervisor.
Independently handle problems that arise within area of responsibility.
Our expectations
Coursework towards a Science Degree e.
g.
Biology or other Sciences, etc.
or Bachelor of Science Degree in related field e.
g.
Microbiology, Biology or other sciences
Must have a minimum of 0-3 years of experience in a regulated industry (e.
g.
, medical devices, pharmaceuticals, etc.
).
Regulatory Affairs experience is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
Preferred to have knowledge of stand
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