What are the responsibilities and job description for the Regulatory Affairs Associate position at IntePros?
IntePros is currently looking for a Regulatory Affairs Associate to join one of our growing Medical Device clients in Audubon, PA. The Regulatory Affairs Associate maintains CE Technical Files and registrations for international Regulatory agencies. This position entails working knowledge of products under review and of relevant regulations and guidance documents. This individual must be enthusiastic, positive, even-tempered and effective in building working relationships with development teams while following ISO, CE, FDA and international/local regulations. Experience should demonstrate dependability, flexibility and attention to detail.
Regulatory Affairs Associate Job Requirements
Regulatory Affairs Associate Job Requirements
- Under supervision of Group Manager, obtain the necessary documentation from Product Development, Quality Assurance, and management needed to maintain existing CE Technical Files.
- Assist in the maintenance of regulatory approval and tracking documents.
- Assemble documentation in support of regulatory submissions.
- Provide regulatory support as needed within Regulatory Affairs.
- Review technical documents intended for submissions.
- Maintain regulatory files.
- Perform literature searches and extract information to support regulatory submissions.
- Assist with review of labeling and clinical reports for regulatory compliance. Assist in the coordination of product labeling revisions for marketing outside the United States.
- File Certificates to Foreign Governments with FDA.
- Monitor FDA and other agency laws and regulations, to ensure company compliance Ensure conformance to ISO, CE, FDA and other international/local regulations.
- Understand spinal and orthopedic surgical techniques and the use of spinal and orthopedic devices and instrument systems.
- Four year college degree or equivalent.
- Experience in a regulated industry such as medical devices is a plus.
- Excellent verbal, written and organizational skills. Good computer skills.
- Must be detail-oriented and able to multi-task.