What are the responsibilities and job description for the Regulatory Affairs Specialist I position at eTeam, Inc.?
Job Description :
- Compile and maintain regulatory documentation databases or systems.
- Coordinate efforts associated with the preparation of regulatory documents or submissions for medical devices (US, EU and Canada submissions). Communicate with internal stakeholders regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation. Conduct regulatory impact assessment for post approval changes and support preparation of necessary submission documentation
Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
ET_HRNHC01
