strong>Requirements System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
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.
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 Title: MDR SpecialistDuration: 6 Months Contracts with possible extension/conversionLocation: Mundelein, IL 60060 (HYBRID, 3 Day Onsite and 2 Day Remote)Pay Range: $28/hr - $30/hrMust Haves: 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.
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.
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.
Related experience may include: Account Manager, Rental Sales, Parts Sales, Service Manager, Customer Service Representative, Construction Manager, Tools Manager, Counter Sales Representative, Equipment Associate, Manager Trainee, Manager in Training, Skilled Craftsman, Brand Ambassador. The Equipment Rental Specialist is an inside sales role responsible supporting telephone and walk-in customers with rentalsof all types of construction/industrial equipment.
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.
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.
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.
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.
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The Regulatory Specialist works closely with Food Scientists, Marketing, Procurement, Project Management, Legal, and Quality teams, while providing support to additional cross-functional teams as needed. With a strong presence across retail and foodservice markets throughout North America, the company is dedicated to delivering high-quality products, preserving tradition, and upholding trusted brands that consumers rely on.
The Regulatory Specialist works closely with Food Scientists, Marketing, Procurement, Project Management, Legal, and Quality teams, while providing support to additional cross-functional teams as needed. Experience with TraceGains, ESHA Genesis or similar food labelling program, SAP, Microsoft Office suite, label review software (Dragonfly or similar), SharePoint, and knowledge of PLM system.
The Payroll Coordinator supports daily payroll operations, ensuring employees are paid accurately, on time, and in compliance with applicable regulations. Support the payroll team in processing payroll for all employees, ensuring accuracy, timeliness, and compliance with U.S. and Canadian regulations.
p>The Plant Health Care Team are specialists dedicated to inspecting plant material, identifying problems, and ethically treating or preventing the many problems that trees and shrubs may face. Through our comprehensive tree, shrub, and lawn care we work hard to make sure our discerning customers have attractive, healthy and cared-for green spaces to enjoy.
Employees do not have to pay premiums if they enroll in the Aetna High Deductible Health Plan or the Kaiser HMO Plan;
Act as the primary administrator for the ADP Workforce Now (Next Gen) payroll platform, maintaining the integrity of employee data and utilizing the Time Labor Management (TLM) system. We are seeking a detail-oriented Payroll and Benefits Specialist to manage the end-to-end payroll and benefits administration for six locations across multiple states.
This role involves coordination across HR Operations, assisting with payroll preparation, employee data management, and HRIS processes, while partnering closely with the management team & other departments. The Payroll & Benefits Specialist supports the day-to-day operations of payroll, benefits, and HR systems.
Employees do not have to pay premiums if they enroll in the Aetna High Deductible Health Plan or the Kaiser HMO Plan;
Our marketplace connects financial advisors and investors to protective investment products - including structured notes, buffered ETFs, and annuities - offered by leading global financial institutions. About Halo: Halo Investing is a fast-growing financial technology firm with a mission to empower investors by providing access to a wide range of protective investment solutions.
The actual base salary offered is determined by a number of variables, including, as appropriate, the applicant's qualifications for the position, years of relevant experience, distinctive skills, level of education attained, certifications or other professional licenses held, and the location of residence and/or place of employment. From transforming parking into a seamless drive-in, drive-out experience for millions of Members to expanding our intelligence layer across retail and hospitality, we are building a world that feels instinctive and magical.
p>As a Employee Benefits Specialist at Elim, you'll be required to: Employee Benefits Administration: Administer employee benefit programs including medical, dental, vision, life insurance, flexible spending, personalized benefits plan, disability insurance, behavioral health support and retirement plans, and wellness initiatives. That's why we foster a positive, team-oriented culture with employee appreciation events and activities throughout the year, including donut and ice cream days, canvas painting parties, a complimentary Thanksgiving lunch, and much more.
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