Regulatory Affairs Associate
The Regulatory Affairs Associate will support, conduct, compile, and review document change notifications for regulatory compliance. This is a direct hire opportunity to join a leading-edge medical device company.
Salary Range: 55-65k
- Support the delivery of regulatory applications for national and international approvals. (FDA 510k, IDE, PMA)
- Compile US FDA, EU and other regional labeling information.
- Submit the appropriate labeling (UDI) to the corresponding labeling database.
- Conduct research to develop additional regulatory knowledge worldwide guidelines based on business needs.
- Review document change notifications for compliance.
- Review design and manufacturing process changes for significant changes which require notification.
- Providing support to the Engineering and R&D teams when it comes to interpretation of regulatory requirements, documents, and other standards.
- Maintain regulatory Affairs files per requirements.
- Support QMS and RA projects to achieve compliance with new or revised requirements.
- BS degree in Engineering (or related discipline) or education/experience equivalency
- 3-5 years of U.S or International or both regulatory requirements experience.
- 1+ year experience with Class 1 or class 2 medical device products and regulations.
- High level of competency in FDA QSRs, ISO 13485, and other regulatory requirements.
- Excellent communication, organization, and prioritization skills.
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