Vigilance Writer
Apex Systems, Acton, MA, United States
Vigilance Writer
Apex Systems is a world class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients’ digital visions.
Job #3027620
We have an opportunity for a Vigilance Writer. Please send your updated resume to [email protected].
Details Position:
Vigilance Writer
Location:
Remote
Project Duration:
5 months
Rate:
Negotiable Bases on Experience
Job Description The Global Product Monitoring Vigilance Report Writer develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices that meet customer, regulatory, and client requirements. The role serves as a post‑market vigilance (reportable event) and surveillance subject‑matter expert and represents the company to improve awareness, visibility, and communication on quality/compliance initiatives to support departmental, divisional, and corporate quality goals and priorities. The candidate will work on problems of diverse scope, evaluating data and selecting appropriate methods to obtain solutions, and network with senior internal and/or external personnel in the area of expertise.
Responsibilities
Assess, follow‑up, code, and perform 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 and ensure proper coding of complaints and reportable events.
Collaborate with engineering, complaint investigation laboratory, medical and other internal staff to review events, coding, and investigation results, ensuring regulatory reporting compliance per procedures, standards, and regulations.
Contribute to departmental non‑conformances escalated into the 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 Microsoft Office (Excel, Word, Outlook) and complaint database applications.
Effective verbal and written communication skills.
Ability to generate, verify, and maintain accurate records.
Analytical skills, detail‑oriented, and strong interpersonal skills.
Ability to influence without authority.
Capacity to organize, judge priorities, and escalate when applicable.
Strong emphasis on and understanding of a formalized medical device quality management system.
Direct experience writing and filing global vigilance reports within the medical device industry.
Working knowledge of global, multi‑country vigilance reporting requirements and demonstrated knowledge of country‑specific differences.
Experience 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.
Requires extensive computer use.
May require up to 10% travel.
Apex Benefits Overview Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability and other insurance plans that provide optional financial protection. Additional benefits include an ESPP (employee stock purchase program) and a 401(k) program that allows contributions typically within 30 days of starting, with a company match after 12 months of tenure. A Health Savings Account (HSA) is also available, along with a SupportLinc Employee Assistance Program (EAP) offering up to eight free counseling sessions, a corporate discount savings program and other discounts.
For professional development, Apex hosts an on‑demand training program and provides access to certification prep and a library of technical and leadership courses once you have six months of tenure, as well as certification discounts and perks from associations that include CompTIA and IIBA.
Contact Information Apex Systems is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, creed, sex, age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with applicable law. If you require an accommodation to search or apply, please contact our Benefits Department at [email protected] or 804‑523‑8228 (do not submit resumes to this email). UnitedHealthcare creates and publishes the Transparency in Coverage Machine‑Readable Files on behalf of Apex Systems.
Company Overview Apex Systems is part of the Commercial Segment of ASGN Incorporated. NYSE: ASGN. 4400 Cox Road, Suite 200, Glen Allen, VA 23060.
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Job #3027620
We have an opportunity for a Vigilance Writer. Please send your updated resume to [email protected].
Details Position:
Vigilance Writer
Location:
Remote
Project Duration:
5 months
Rate:
Negotiable Bases on Experience
Job Description The Global Product Monitoring Vigilance Report Writer develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices that meet customer, regulatory, and client requirements. The role serves as a post‑market vigilance (reportable event) and surveillance subject‑matter expert and represents the company to improve awareness, visibility, and communication on quality/compliance initiatives to support departmental, divisional, and corporate quality goals and priorities. The candidate will work on problems of diverse scope, evaluating data and selecting appropriate methods to obtain solutions, and network with senior internal and/or external personnel in the area of expertise.
Responsibilities
Assess, follow‑up, code, and perform 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 and ensure proper coding of complaints and reportable events.
Collaborate with engineering, complaint investigation laboratory, medical and other internal staff to review events, coding, and investigation results, ensuring regulatory reporting compliance per procedures, standards, and regulations.
Contribute to departmental non‑conformances escalated into the 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 Microsoft Office (Excel, Word, Outlook) and complaint database applications.
Effective verbal and written communication skills.
Ability to generate, verify, and maintain accurate records.
Analytical skills, detail‑oriented, and strong interpersonal skills.
Ability to influence without authority.
Capacity to organize, judge priorities, and escalate when applicable.
Strong emphasis on and understanding of a formalized medical device quality management system.
Direct experience writing and filing global vigilance reports within the medical device industry.
Working knowledge of global, multi‑country vigilance reporting requirements and demonstrated knowledge of country‑specific differences.
Experience 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.
Requires extensive computer use.
May require up to 10% travel.
Apex Benefits Overview Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability and other insurance plans that provide optional financial protection. Additional benefits include an ESPP (employee stock purchase program) and a 401(k) program that allows contributions typically within 30 days of starting, with a company match after 12 months of tenure. A Health Savings Account (HSA) is also available, along with a SupportLinc Employee Assistance Program (EAP) offering up to eight free counseling sessions, a corporate discount savings program and other discounts.
For professional development, Apex hosts an on‑demand training program and provides access to certification prep and a library of technical and leadership courses once you have six months of tenure, as well as certification discounts and perks from associations that include CompTIA and IIBA.
Contact Information Apex Systems is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, creed, sex, age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with applicable law. If you require an accommodation to search or apply, please contact our Benefits Department at [email protected] or 804‑523‑8228 (do not submit resumes to this email). UnitedHealthcare creates and publishes the Transparency in Coverage Machine‑Readable Files on behalf of Apex Systems.
Company Overview Apex Systems is part of the Commercial Segment of ASGN Incorporated. NYSE: ASGN. 4400 Cox Road, Suite 200, Glen Allen, VA 23060.
#J-18808-Ljbffr