Job Title: Vigilance Writer

Duration: 3+ months (possibility of extension & conversion depending on the performance) Location: Acton, MA - Remote Pay Rate: $43 - $45/hr hourly on W2 Job description: 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.

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.

Minimum Requirements

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.

Preferred Skills and Competencies

Strong proficiency in common computer applications such as MS 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.

Travel and Physical Requirements

General office environment - may sit for long periods of time. This position requires extensive computer use.

May require up to 10% travel

Desired Skills and Experience

Job Title: Vigilance Writer

Duration: 3+ months (possibility of extension & conversion depending on the performance) Location: Acton, MA - Remote Pay Rate: $43 - $45/hr hourly on W2

Job description

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.

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.

Minimum Requirements

• 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.

Preferred Skills and Competencies

• Strong proficiency in common computer applications such as MS 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.

Travel and Physical Requirements

• General office environment - may sit for long periods of time.

• This position requires extensive computer use.

• May require up to 10% travel

Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.

Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals. To learn more, please visit https://dexian.com/.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.