Regulatory Affairs Associate - Randstad : Job Details

New manufacturing site in France due to acquiring new business . Contractor needed to complete 3 separate projects for CMC clinical/regulatory submissions. location: North Chicago, Illinois job type: Contract salary: $40 - 50 per hour work hours: 9 to 5 education: Bachelors responsibilities: Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for produ[ \r\n\t. Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.\r\n\t. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).\r\n\t. Review/approval of engineering study protocols/reports and validation study protocols/reports.\r\n\t. Review and approval of manufacturing changes for Class III implantable medical devices. \r\n\t. Recent experience with Class III implantable medical devices\r\n\t....Regulatory Affairs, Associate, Regulatory, Business Services, Staffing, Manufacturing