[Remote] Vigilance Writer

Note: The job is a remote job and is open to candidates in USA. HonorVet Technologies provides specialized staffing solutions to various organizations in the life sciences sector. They are seeking a Vigilance Writer to develop and maintain quality assurance methodologies and serve as a subject matter expert in post-market vigilance and regulatory reporting compliance.ResponsibilitiesResponsible for the assessment, follow-up, coding, and vigilance activities for complaints globallyAuthor, peer review, and approve vigilance reports to ensure on time submissions to the appropriate regulatory authoritiesSupport management in day-to-day operations in a fast-paced work environment; Support proper coding of complaints and reportable eventsCollaborate 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 regulationsContribute to departmental non-conformances escalated into CAPA SystemServe as a subject matter expert for post-market and complaint handling regulatory questions and inquiriesSupport internal and external audits and inspectionsAssist with special projects, as assigned, with minimal supervisionPerform other duties as requiredSkillsBachelor's degree or appropriate combination of relevant education and experienceDemonstrated experience in medical device complaint triage and vigilance reporting or clinical experience in diabetes disease management or diabetes device supportStrong proficiency in common computer applications such as Microsoft Office (Excel, Word, Outlook) and complaint database applicationsEffective verbal and written communication skillsAbility to generate, verify, and maintain accurate recordsMust have analytical skills, be detail oriented, and have good interpersonal skillsDemonstrated ability to influence without authorityAbility to organize, judge priorities, and escalate when applicableStrong emphasis and understanding of a formalized medical device Quality Management SystemDirect experience of writing and filing global vigilance reports within the medical device industryWorking knowledge/experience with global, multi-country vigilance reporting requirements for medical devices and demonstrated knowledge of country-specific differences and requirementsExperience in dealing directly with regulatory bodies is highly desiredBSN with diabetes experience, Registered or Licensed Dietician or Diabetic Educator, preferredCompany OverviewHonorVet Technologies is a technology driven company providing a large staffing solution with the feel of a specialized,boutique provider. It was founded in 2015, and is headquartered in Fairfield, New Jersey, USA, with a workforce of 501-1000 employees. Its website is https://honorvettech.com/.