Job Details

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.

Apex has an opportunity for anVigilance Writer. For applicants who are interested in thisopportunity, send your updated resume to [email protected] .

Here are the details:

Position:Vigilance Writer

Location: Remote

Project Duration: 5 months

Rate:Negotiable Bases on Experience

JOB DESCRIPTION

TheGlobal Product Monitoring Vigilance Report Writerdevelops, 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 theappropriate regulatoryauthorities.
• 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.
• Assistwith special projects, as assigned, with minimal supervision.
• Perform other duties asrequired.

Minimum Requirements:

• Bachelor's degree orappropriate combinationof 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:

• Strongproficiencyin common computer applications such as Microsoft Office (Excel, Word, Outlook) and complaint database applications.
• Effective verbal and written communication skills.
• Ability to generate, verify, andmaintainaccuraterecords.
• 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 medicaldeviceQuality 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 anddemonstratedknowledge 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 forlong periodsof time.
• This position requires extensive computer use.
• May require up to 10% travel

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join 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. Apex uses a virtual recruiter as part of the application process. Click here for more details.

Apex Benefits Overview: 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. 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, 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. 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 Apex team member can provide.