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Vigilance Report Writer

Atrium

Chicago, IL

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JOB DETAILS
SALARY
$45–$49 Per Hour
SKILLS
Analysis Skills, Artificial Intelligence (AI), Biology, Cross-Functional, Data Collection, Detail Oriented, Diversity, Document Management, Documentation, FDA (Food and Drug Administration), Genetics, Healthcare, Interviewing Skills, Maintain Compliance, Medical Equipment, Medical Organizations, Microsoft Office, Patient Safety, Project/Program Management, Record Keeping, Regulations, Regulatory Compliance, Regulatory Reports, Regulatory Requirements, Regulatory Submissions, Reporting Skills, Short Messaging Service (SMS), Team Player, Technical Writing, Time Management, Writing Skills
LOCATION
Chicago, IL
POSTED
16 days ago
Client Overview:
Our client is a rapidly expanding medical device organization focused on delivering innovative healthcare solutions. The company is recognized for its commitment to quality and patient safety and fosters a collaborative environment that values professional development and diversity. They are now looking for a Vigilance Report Writer.

Salary/Hourly Rate:
$45/hr - $49/hr

Position Overview:
The Vigilance Report Writer is responsible for preparing and submitting regulatory reports related to medical device incidents. This role ensures compliance with global regulations and supports the company's commitment to patient safety.

Responsibilities of the Vigilance Report Writer:
  • Draft and review vigilance reports for medical device incidents.
  • Ensure reports meet regulatory requirements and deadlines.
  • Collaborate with cross-functional teams to gather incident data.
  • Maintain accurate records and documentation.
  • Monitor regulatory updates and adjust reporting practices accordingly.
  • Support audits and inspections by providing relevant documentation.
  • Communicate with regulatory authorities as needed.
Required Experience/Skills for the Vigilance Report Writer:
  • Strong written communication and technical writing skills.
  • Familiarity with medical device regulations (e.g., FDA, MDR).
  • Strong attention to detail and accuracy.
  • Ability to analyze and interpret incident data.
  • Proficiency in Microsoft Office and document management systems.
  • Experience working in a regulated environment.
Preferred Experience/Skills for the Vigilance Report Writer:
  • Previous experience in medical device vigilance or regulatory affairs.
  • Knowledge of global regulatory requirements.
  • Experience with electronic reporting systems.
  • Project management skills.
Education Requirements:
  • Bachelor's degree in life sciences, engineering, or a related field.
Benefits:
  • Atrium Care Package available upon eligibility (including healthcare plans, discount programs, and paid time off).
About Atrium:What you do matters. Guided by our Applicant-Centric™ approach, we foster an environment of collaboration, high performance, and innovation where your talents are valued, and your achievements are celebrated. Join us and become part of an inclusive team committed to your growth and success.
By applying to this job, you agree to receive calls, AI-generated calls, text messages, and/or emails from Atrium and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to opt out on any message you receive. For more details, please review our Terms of Use and Privacy Policy .

As a woman-owned firm, we value diversity. We are an equal opportunity and affirmative action employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Candidates who apply for roles through the Atrium website will be added to our candidate pool and may be considered for additional roles of a similar title. Please contact us to request an accommodation.
EOE/M/F/D/V/SO

Position ID: 394289

About the Company

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Atrium