Regulatory Compliance Engineer

Working at Freudenberg: We will wow your world!

Responsibilities:

Assists in the completion and assembly of regulatory submissions (both international and domestic).
Maintains regulatory files including submissions, technical files, etc.
Assists in regulatory body, internal & external audits, product recalls, Vigilance and MDR reportability, as necessary.
Interfaces with customer service and engineering on customer complaints and complaint investigations.
Ensures customer complaints, MDR’s and global vigilance reporting are addressed in a timely manner according to the risk level per company and regulatory standards.
Assists customer service and quality team in improving the customer complaint process and procedures.
Management of domestic and international standards, directives, regulations, etc. for gap analysis according to the latest revision.
Independently handle problems that arise within area of responsibility.
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