Global RA Specialist

Coopersurgical • Victor, NY

251d • $41,683 • Remote

About The Position

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.
• 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).
• One year of experience performing gap assessments for internal processes and developing regulatory strategies for medical devices and reviewing standard operating procedures.
• One year of experience with pharmaceutical quality assurance practices including, risk management, writing deviation reports, and corrective and preventative actions.
• Six months of experience conducting internal and external audits.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree