- Evaluate adverse events and medically related complaints for on-market products to determine seriousness, reportability, and potential causality.
- Classify, review, and disposition adverse events and complaints in accordance with company procedures and regulatory requirements.
- Complete FDA Medical Device Reporting (MDR) submissions and other regulatory reports for competent authorities.
- Collaborate cross-functionally with other departments including Regulatory Affairs, Quality Assurance, and Clinical Affairs to ensure timely and accurate reporting.
- Maintain accurate and up-to-date records of adverse event reports and complaint investigations.
- Participate in internal and external audits related to post market surveillance activities.
- Bachelor's degree in a healthcare or science-related field preferred; or Associate's degree with relevant experience supporting complaint handling investigations, medical device reporting, or product analysis.
- Related experience in post market surveillance within the Medical Device or Pharmaceutical Industry preferred.
- Knowledge of FDA regulations and international regulatory requirements related to post market surveillance.
- Strong analytical skills with the ability to assess complex situations and make sound decisions.
- Excellent written and verbal communication skills.
- Detail-oriented with strong organizational skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Proficiency in Microsoft Office suite and experience with complaint handling software preferred.
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The Fortus Group, Inc. Minneapolis, United StatesFortus Healthcare Resources is seeking a Travel Medical Lab Technician Laboratory for an immediate opening in Minneapolis, MN . Lab Technician, Technician, Medical, Laboratory, Lab, Lab, Healthcare, Staffing ...
Laboratory Technician - Minneapolis, United States - Collabera
Description
We are seeking a detail-oriented and motivated Post Market Surveillance Specialist to join our team. The ideal candidate will have experience in post market surveillance within the Medical Device or Pharmaceutical Industry. However, candidates with relevant education and a passion for healthcare or science will also be considered. The primary responsibilities of this role include evaluating adverse events and complaints for on-market products, ensuring compliance with regulatory requirements, and completing regulatory reports for submission to competent authorities.
Responsibilities:
Requirements:
