Our client is seeking a Post Market Analyst in the Northeast!
Our client is one of the largest provider of medical devices, with a focus in implants to treat peripheral vascular disease. They are creating innovative disposable and implantable vascular devices to address patient needs. This position will offer experiences in project oversight, management, and direct support of engineers, manufactures, sales, and other experts solve applicable issues.
- Process complaints and regulatory (MDR, Vigilance, other) reports to ensure that complaints are documented, reviewed, evaluated, investigated, and formally closed in a timely manner
- Interface directly with internal and external customers and regulatory agencies as required
- Prepare and contribute to responses to regulatory inquiries as needed
- Support quality metrics development and monitoring, participating in regular business and quality system performance reviews
- Review complaint data and prepare reports for internal customers as needed
- Provide support for other quality functions as needed, including field actions, corrective actions, and others
- Responsible and accountable for carrying out the requirements of the company’s quality system
- BS in related field
- 2+ years in medical device or biotechnology industry, with understanding of regulatory agency (cGMP/ISO) requirements for complaint management
- 1+ years complaint handling experience including initiation through closure
- 1+ years independent post-market regulatory reporting experience (MDR and/or Vigilance), drafting and submitting
- Experience in negotiation, presentations, and interpersonal communication skills
- Experience in time management, problem solving, analytics, and computer skills