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Post-Market Surveillance Consultant

Company: Eliassen Group
Location: Somerville
Posted on: June 18, 2022

Job Description:

We have an excellent job opportunity available as a Post-Market Surveillance consultant. You must have knowledge of regulations relative to complaint handling and reporting, such as: ISO 13485/14971, FDA Regulations (21CFR (803, 806, 820)), CMDR, JPAL, TG(MD)R, and EU MDR.

Duration: 6 months

Our client is looking for this consultant to:
Create, review, and approve incident reporting decision trees
Create and ensure timely submission of adverse event reporting to applicable regulatory agencies such as the FDA, Health Canada, MHLW, TGA, Competent Authorities, and authorized Representatives
Ensure product complaints are investigated per procedures
Continuously review complaints status and update file with progress and information findings to ensure all required information is submitted to the appropriate regulatory agency in a timely manner
Maintain adverse event reporting log to ensure all reportable events are captured and reported per regulation
Maintain adverse event files electronically to support compliance with regulatory requirements
Compile, analyze and report production and post-production information as part of the Post-Market Surveillance system
Perform data trending and statistical analysis
Direct involvement in adverse event reporting activities is required

Job ID: 367853 About EG Life Sciences:

Founded in 2010, EG Life Sciences is a national professional services firm that delivers strategic consulting and innovative solutions for the pharmaceutical, biologic, medical device, and diagnostic industries. We provide tailored services to clients seeking to manage challenges, improve time-to-market, and fine-tune clinical development and operations. Our team is comprised of dedicated professionals and FDA-regulated industry specialists, each averaging over 20 years of related experience. This combination of services and team members enables us to quickly deliver value-driven life sciences consulting, project management and leadership, and customized project-based solutions.

Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!

Keywords: Eliassen Group, Somerville , Post-Market Surveillance Consultant, Professions , Somerville, Massachusetts

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