Global Vigilance Report Writer

Now Hiring: Global Vigilance Report Writer

Location: Acton, MA (Remote)

Pay: Up to $45.50/hour

We are seeking an experienced Global Vigilance Report Writer for a temporary remote opportunity supporting medical device quality and regulatory compliance activities. This position plays a key role in post-market surveillance, complaint handling, vigilance reporting, and regulatory submissions to ensure compliance with global medical device regulations.

Job Duties

• Review, assess, code, and manage medical device complaints and reportable events.
• Author, review, and submit global vigilance reports within required regulatory timelines.
• Partner with engineering, quality, medical, and investigation teams to support event evaluations and reporting decisions.
• Maintain accurate documentation and ensure compliance with quality management system requirements.
• Support CAPA activities, audits, inspections, and regulatory inquiries.
• Serve as a subject matter expert for complaint handling, post-market surveillance, and vigilance reporting.
• Assist with special projects and continuous improvement initiatives.

Qualifications

• Bachelor's degree or equivalent combination of education and experience.
• Experience with medical device complaint handling, vigilance reporting, post-market surveillance, or regulatory reporting required.
• Knowledge of global medical device reporting requirements and regulatory compliance standards.
• Strong analytical, documentation, and problem-solving skills.
• Proficiency with Microsoft Office and quality or complaint management systems.
• Excellent written and verbal communication skills.
• Experience interacting with regulatory agencies is highly preferred.
• Clinical backgrounds including nursing, diabetes education, or dietetics are a plus.

Physical Requirements

• Remote office environment with extensive computer use.
• Ability to sit for extended periods.
• Up to 10% travel may be required.

Benefits

• Medical, Dental, Vision & Pet Insurance
• 401(k) Retirement Savings Plan
• Health Savings Account (HSA)
• Employee Assistance Program (EAP)
• Commuter & Parking Accounts
• AD&D Insurance
• People Perks Employee Discount Program

Click "Apply Now" to get started.

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.