Regulatory Affairs Specialist - Vigilance

CooperVision, Inc. seeks a Global RA Specialist in Victor, NY to coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. Coordinate efforts associated with the preparation of regulatory documents or submissions. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. Prepare additional information or responses as requested by regulatory agencies. Coordinate, prepare, or review regulatory submissions for domestic or international projects. Prepare or maintain technical files as necessary to obtain and sustain product approval. Support global vigilance activities, focusing on Adverse Event monitoring and reporting, as well as generating Periodic Safety Update Reports (PSUR) and templates. Maintain regulatory files for adverse event/incident reporting, recall, and post-market surveillance. Analyze and improve processes that are used to handle adverse event/incident reporting, post market surveillance, and recall. 100% remote work permitted. Requirements: Bachelor’s degree in regulatory affairs or related field plus one year of experience with medical device safety signaling, analyzing regulations and international standards, and submitting medical device reports to Ministries of Health (MoHs) or Competent Authority (CA). 1 year of experience performing gap assessments for internal processes and developing regulatory strategies for medical devices and reviewing standard operating procedures. 1 year of experience with pharmaceutical quality assurance practices including, risk management, writing deviation reports, and corrective and preventative actions. 6 months of experience conducting internal and external audits. The expected salary for the position is $41,683. Please respond online to http://coopervision.com/careers - position #7554.