Global Vigilance Report Writer (Remote)
Advantage Technical, Acton, MA, United States
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.
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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