Note: The job is a remote job and is open to candidates in USA. LanceSoft, Inc. is recruiting a Vigilance Writer to support global medical device post-market monitoring and regulatory compliance. The role assesses and codes complaints, authors and reviews vigilance reports, collaborates on investigations and regulatory submissions, and supports audits, CAPA activities, and quality initiatives.
Responsibilities
- Responsible for the assessment, follow-up, coding, and vigilance activities for complaints globally
- Author, peer review, and approve vigilance reports to ensure on time submissions to the appropriate regulatory authorities
- Support management in day-to-day operations in a fast-paced work environment; Support proper coding of complaints and reportable events
- 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
- Contribute to departmental non-conformances escalated into CAPA System
- Serve as a subject matter expert for post-market and complaint handling regulatory questions and inquiries
- Support internal and external audits and inspections
- Assist with special projects, as assigned, with minimal supervision
- Perform other duties as required
Skills
- Bachelor's degree or appropriate combination of relevant education and experience
- Demonstrated experience in medical device complaint triage and vigilance reporting or clinical experience in diabetes disease management or diabetes device support
- Strong proficiency in common computer applications such as Microsoft Office (Excel, Word, Outlook) and complaint database applications
- Effective verbal and written communication skills
- Ability to generate, verify, and maintain accurate records
- Must have analytical skills, be detail oriented, and have good interpersonal skills
- Demonstrated ability to influence without authority
- Ability to organize, judge priorities, and escalate when applicable
- Strong emphasis and understanding of a formalized medical device Quality Management System
- Direct experience of writing and filing global vigilance reports within the medical device industry
- Working knowledge/experience with global, multi-country vigilance reporting requirements for medical devices and demonstrated knowledge of country-specific differences and requirements
- Experience in dealing directly with regulatory bodies is highly desired
- BSN with diabetes experience, Registered or Licensed Dietician or Diabetic Educator, preferred
- General office environment – may sit for long periods of time
- This position requires extensive computer use
- May require up to 10% travel
Benefits
- Remote US
- Contract (Full Time)
Company Overview
Company H1B Sponsorship