<p>Client Overview:</p> <p>Our client is a rapidly expanding medical device organization focused on delivering innovative healthcare solutions. The company is recognized for its commitment to quality and patient safety and fosters a collaborative environment that values professional development and diversity. They are now looking for a Vigilance Report Writer.</p> <p>Salary/Hourly Rate:</p> <p>$45/hr - $49/hr</p> <p>Position Overview:</p> <p>The Vigilance Report Writer is responsible for preparing and submitting regulatory reports related to medical device incidents. This role ensures compliance with global regulations and supports the company's commitment to patient safety.</p> <p>Responsibilities of the Vigilance Report Writer:</p> <ul> <li>Draft and review vigilance reports for medical device incidents. </li><li>Ensure reports meet regulatory requirements and deadlines. </li><li>Collaborate with cross-functional teams to gather incident data. </li><li>Maintain accurate records and documentation. </li><li>Monitor regulatory updates and adjust reporting practices accordingly. </li><li>Support audits and inspections by providing relevant documentation. </li><li>Communicate with regulatory authorities as needed. </li></ul> <p>Required Experience/Skills for the Vigilance Report Writer:</p> <ul> <li>Strong written communication and technical writing skills. </li><li>Familiarity with medical device regulations (e.g., FDA, MDR). </li><li>Strong attention to detail and accuracy. </li><li>Ability to analyze and interpret incident data. </li><li>Proficiency in Microsoft Office and document management systems. </li><li>Experience working in a regulated environment. </li></ul> <p>Preferred Experience/Skills for the Vigilance Report Writer:</p> <ul> <li>Previous experience in medical device vigilance or regulatory affairs. </li><li>Knowledge of global regulatory requirements. </li><li>Experience with electronic reporting systems. </li><li>Project management skills. </li></ul> <p>Education Requirements:</p> <ul> <li>Bachelor's degree in life sciences, engineering, or a related field. </li></ul> <p>Benefits:</p> <ul> <li>Atrium Care Package available upon eligibility (including healthcare plans, discount programs, and paid time off). </li></ul>