What are the responsibilities and job description for the Vigilance Writer position at Advantage Technical?
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 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.
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
The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs.
Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies.
Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.
Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.