strong>Requirements System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
Our more than 25,000 team members and more than 6,000 physicians aim to deliver transformative patient experiences and expert care close to home across more than 300 ambulatory locations and eight acute care hospitals – Edward (Naperville), Elmhurst, Evanston, Glenbrook (Glenview), Highland Park, Northwest Community (Arlington Heights) Skokie and Swedish (Chicago) – all recognized as Magnet hospitals for nursing excellence. Please explore our website (www.endeavorhealth.org) to better understand how Endeavor Health delivers on its mission to “help everyone in our communities be their best”.
5+ years of experience in complaint handling, adverse event reporting, MDR evaluation, post-market surveillance, or regulatory affairs within the medical device or pharmaceutical industry Strong working knowledge of FDA Medical Device Reporting regulations (21 CFR 803) and complaint handling requirements (21 CFR 820.198) Experience preparing and submitting MDRs through the FDA eMDR portal, including completion of FDA Form 3500A Ability to evaluate complaint narratives, determine reportability, and apply FDA coding for adverse events, malfunctions, injuries, and deaths Strong verbal and written communication skills with the ability to collaborate effectively across Quality, Regulatory Affairs, R&D, and Operations teams Experience with quality documentation processes, verification activities, DMR/DMRC documentation, and HIPAA-compliant recordkeeping Proficiency with MS Suite and complaint management systems such as SAP, TrackWise, or similar platforms Bachelor’s degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, Healthcare, or a related field Mission: Support post-market surveillance and regulatory compliance efforts by reviewing product complaints, determining MDR reportability, and ensuring all adverse event submissions are completed accurately and in accordance with FDA requirements, including 21 CFR 803 and Quality System regulations.
Job Description: 5 years of experience in complaint handling, adverse event reporting, MDR evaluation, post-market surveillance, or regulatory affairs within the medical device or pharmaceutical industry. Experience preparing and submitting MDRs through the FDA eMDR portal, including completion of FDA Form 3500A.
The specialist will prepare and submit MDRs through the FDA eMDR portal, including completion of FDA Form 3500A and assignment of appropriate FDA codes. Collabera is looking for an Adverse Event Specialist to review both new and historical product complaints to assess data completeness and determine MDR reportability.
li>Collaborate with Central Marketing teams—including Content, Design, Video, Studio, Web, SEO—and critical partners such as Compliance and Online Reputation Management to ensure accuracy, brand alignment, and regulatory adherence. The Social Media Manager, North America, is responsible for planning, producing, and delivering social media content across marketing and multiple business areas, with a specific focus on commercial and global self-directed audiences.
CONSIDERED EXPERIENCE INCLUDES: Tax Accountant Attorney Mergers Acquisitions Divestitures Equity Funds Tax JD CPA MBA Representations Warranties Insurance RWI Transactional Risk Insurance #DiedreMoire #JobSearch #JobHunt #JobOpening #Hiring #Job #Jobs #Careers #Employment #jobposting #InsuranceJobs. Shall: • Determine acceptability of Representations and Warranties Insurance and Transactional Risk Insurance options for Mergers and Acquisitions deals using high level financial risk analysis and negotiating with buyers and sellers.
CONSIDERED EXPERIENCE INCLUDES: Insurance Claims Examiner Adjuster Specialist Professional Liability Medical Malpractice MedMal Allied Healthcare #DiedreMoire #JobSearch #JobHunt #JobOpening #Hiring #Job #Jobs #Careers #Employment #jobposting #InsuranceJobs #UnderwriterJobs. Described compensation is not definite nor precise and may be estimated and approximate and is negotiable depending on market conditions and candidate availability and other factors and is solely at the discretion of employers.
Finally, Lehigh Valley Hospital - Cedar Crest, Lehigh Valley Hospital - Muhlenberg, Lehigh Valley Hospital- Hazleton, and Lehigh Valley Hospital - Pocono each received an 'A' grade on the Hospital Safety Grade from The Leapfrog Group in 2020, the highest grade in patient safety. We're a Magnet(tm) Hospital, having been honored five times with the American Nurses Credentialing Center's prestigious distinction for nursing excellence and quality patient outcomes in our Lehigh Valley region.
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