Vigilance Writer

Vigilance Writer - Medical Devices

Location: Acton, MA

Pay Rate: $46.00/hour

We are seeking a detail-oriented Vigilance Writer to support global medical device complaint handling and post-market surveillance activities. This role is responsible for evaluating complaint events, preparing regulatory vigilance reports, and ensuring compliance with global medical device reporting requirements.

Key Responsibilities:

* Assess, review, and code medical device complaints and reportable events

* Author, review, and submit global vigilance reports to regulatory authorities within required timelines

* Collaborate with engineering, quality, medical, and investigation teams to support compliance and reporting accuracy

* Support complaint handling, CAPA activities, audits, and regulatory inspections

* Serve as a subject matter expert for post-market surveillance and vigilance reporting processes

* Maintain accurate records and documentation within complaint management systems

* Assist with special projects and continuous quality improvement initiatives

Qualifications:

* Bachelor's degree or equivalent combination of education and experience

* Experience with medical device complaint handling, vigilance reporting, or post-market surveillance required

* Strong understanding of medical device quality systems and regulatory compliance

* Experience writing and filing global vigilance reports preferred

* Familiarity with multi-country regulatory reporting requirements highly desired

* Proficiency with Microsoft Office and complaint database systems

* Strong analytical, organizational, and communication skills

Preferred Background:

* Clinical experience in diabetes management or diabetes device support

* BSN, Registered Dietician, or Certified Diabetes Educator experience preferred

* Experience interacting directly with regulatory agencies is a plus

Employee Benefits:

* Medical, dental, vision, and pet insurance

* 401(k) Retirement Savings Plans

* Employee Assistance Program (EAP)

* Commuter/Parking Accounts

* People Perks

* Health Savings Account (HSA)

* AD&D Insurance

If you have experience in medical device vigilance reporting and regulatory compliance, click "Apply Now" today.

Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies.

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