<p>Job#: 3031925</p> <p>Job Description:</p> <p>Apex Systems is a world class technology services business that incorporates industry or insights and experience to deliver solutions that fulfill our clients' digital visions.</p> <p>Apex has an opportunity for an Vigilance Writer. For applicants who are interested in this opportunity, send your updated resume to [email protected].</p> <p>Here are the details:</p> <p>Position: Vigilance Writer</p> <p>Location: Remote</p> <p>Project Duration: 3 months</p> <p>Rate: Negotiable Bases on Experience</p> <p>JOB DESCRIPTION</p> <p>The Global Product Monitoring Vigilance Report Writer develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices which meet customer, regulatory, and client requirements; serves as a post-market vigilance (reportable event) and surveillance subject matter expert and representative to improve awareness, visibility, and communication on quality/compliance initiatives to support departmental, divisional, and corporate quality goals and priorities; works on problems of diverse scope where analysis of data requires evaluation of identifiable factors; demonstrates good judgment in selecting methods and techniques for obtaining solutions; and networks with senior internal and/or external personnel in own area of expertise.</p> <p>Responsibilities:</p> <ul> <li>Responsible for the assessment, follow-up, coding, and vigilance activities for complaints globally. </li><li>Author, peer review, and approve vigilance reports to ensure on time submissions to the appropriate regulatory authorities. </li><li>Support management in day-to-day operations in a fast-paced work environment; Support proper coding of complaints and reportable events. </li><li>Collaborate with engineering, complaint investigation laboratory, medical and other internal staff as applicable to review events, coding, and investigation results to support regulatory reporting compliance occurs per procedures, standards, and regulations. </li><li>Contribute to departmental non-conformances escalated into CAPA System </li><li>Serve as a subject matter expert for post-market and complaint handling regulatory questions and inquiries. </li><li>Support internal and external audits and inspections. </li><li>Assist with special projects, as assigned, with minimal supervision. </li><li>Perform other duties as required. </li></ul> <p>Minimum Requirements:</p> <ul> <li>Bachelor's degree or appropriate combination of relevant education and experience. </li><li>Demonstrated experience in medical device complaint triage and vigilance reporting or clinical experience in diabetes disease management or diabetes device support. </li></ul> <p>Preferred Skills and Competencies:</p> <ul> <li>Strong proficiency in common computer applications such as Microsoft Office (Excel, Word, Outlook) and complaint database applications. </li><li>Effective verbal and written communication skills. </li><li>Ability to generate, verify, and maintain accurate records. </li><li>Must have analytical skills, be detail oriented, and have good interpersonal skills. </li><li>Demonstrated ability to influence without authority. </li><li>Ability to organize, judge priorities, and escalate when applicable. </li><li>Strong emphasis and understanding of a formalized medical device Quality Management System. </li><li>Direct experience of writing and filing global vigilance reports within the medical device industry. </li><li>Working knowledge/experience with global, multi-country vigilance reporting requirements for medical devices and demonstrated knowledge of country-specific differences and requirements. </li><li>Experience in dealing directly with regulatory bodies is highly desired. </li><li>BSN with diabetes experience, Registered or Licensed Dietician or Diabetic Educator, preferred. </li></ul> <p>Travel and Physical Requirements:</p> <ul> <li>General office environment - may sit for long periods of time. </li><li>This position requires extensive computer use. </li><li>May require up to 10% travel </li></ul> <p>Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Everforth Apex uses a virtual recruiter as part of the application process. Click here for more details.</p> <p>Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide.</p> <p>Employee Type:</p> <p>Contract</p> <p>Remote:</p> <p>Yes</p> <p>Location:</p> <p>Acton, MA, US</p> <p>Job Type:</p> <p>Scientific and Clinical</p> <p>Date Posted:</p> <p>April 23, 2026</p> <p>Pay Range:</p> <p>$40 - $46 per hour</p> <p>Similar Jobs</p> <ul> <li>Tech Writer </li><li>Tech Writer </li><li>Technical Writer </li><li>Technical Writer </li><li>Technical Writer </li></ul>