Global Vigilance Report Writer (Remote)

Help Drive Safety and Quality in Life-Changing Medical Technology Join an innovative organization focused on improving patient lives through advanced medical technology. As a Global Vigilance Report Writer, you will play a critical role in post-market surveillance, complaint handling, and regulatory reporting, ensuring global compliance and patient safety. What You'll Do Assess, follow up, and code global product complaints and reportable events Author, review, and approve vigilance reports for timely regulatory submission Ensure compliance with global medical device reporting regulations Collaborate with engineering, clinical, and quality teams on investigations and event assessments Support complaint coding accuracy and post-market surveillance activities Contribute to CAPA investigations and quality system improvements Serve as a subject matter expert for vigilance and complaint handling processes Support internal/external audits and regulatory inspections Assist with special projects in a fast-paced environment What You Bring Bachelor's degree or equivalent experience Experience in medical device complaint handling and vigilance reporting or clinical experience in diabetes/device support Strong knowledge of global vigilance reporting requirements and regulatory standards Experience writing and submitting global vigilance reports preferred Familiarity with Quality Management Systems (QMS) and CAPA processes Proficiency in Microsoft Office and complaint management systems Strong analytical, documentation, and communication skills Ability to prioritize, work independently, and influence cross-functional teams Preferred Background Experience working directly with regulatory authorities BSN, Registered Dietitian, or Certified Diabetes Educator (preferred) Why This Role Competitive pay up to $45/hour Hybrid schedule with onsite collaboration High-impact role supporting global patient safety and compliance Opportunity to work cross-functionally within a growing medical device organization Advantage Technical Benefits Medical, dental, and vision insurance. 401k options. Weekly pay via direct deposit. Referral bonus potential. Employee discount programs and more! If you have experience in medical device vigilance reporting and complaint handling, apply now to be considered for this high-impact opportunity. Apply Now. The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs. About Us Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies. Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help. #J-18808-Ljbffr