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Post Market Surveillance Analyst

Bedford, MA 01803

Posted: 03/01/2022 Industry: Manufacturing Operations Job Number: 14013

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

 

Title: Post Market Surveillance Analyst

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

  • Duration: Perm
  • Pay rate: $80k
  • Job Location: Bedford, MA
  • Job#: bh 14013

 

 

Post Market Surveillance Analyst



Overview

Responsible for supporting activities associated with complaint handling and regulatory reporting submissions. Responsible for the oversight, management and direct support of investigational tasks required for complaint processing through to closure. Partner with Engineering, Manufacturing, Marketing, Sales, Customer Support, and other functional experts as needed to ensure a clear understanding and an investigation of applicable issues.

Responsibilities

  • 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.

 

Qualifications

  • 4 Year / Bachelor's Degree
  • 2+ years in the medical device or biotechnology industry, with hands-on, in-depth knowledge and 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.
  • Demonstrated verbal, written, presentation, negotiation, and interpersonal communication skills. Able to professionally represent the company to medical professionals, regulators, and customers.
  • Demonstrated organizational, time management, problem solving, analytical, and computer skills, with a strong attention to detail.
  • Demonstrated ability to follow complex operating procedures and take direction and feedback.

 

 

Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.

 

When responding to this job posting you MUST include the Job# and Job Title in your subject line.

 

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