Regulatory Specialist

Manpower, Inc. of SE Michigan is currently seeking a Regulatory Specialist for our client in Chelsea, MI. This is a temp-to-hire opportunity paying $15.00 - 20.00 per hour. Job duties include: *Demonstrate a working knowledge of cGMPs as defined in 21 CFR 820 Subchapter H for Medical Devices. *Review product records to confirm that Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) requirements are met. *Confirm device history record under review meets requirements as stated in the device master record (DMR) for the product under review. *Verify factors of identity and traceability such as part-match, count, materials issued and lot numbers on all Device History Records (DHR) are accurate against source information such as the DMR and Receiving documents for materials. *Review batch records (job packets) to ensure that they are correct, complete and legible according to GMP requirements. *Check work orders and other documentation to ensure compliance with operating and regulatory requirements per work instructions or as listed in 21 CFR 820 sections Subpart H - Acceptance Activities, Section 820.80 and Subpart M - Records, Section 820.184 Device history record. *Utilize the DHR (Device History Record) review checklist to assure consistency to the review process. Note that this checklist becomes part of the product record and as such, you as reviewer are responsible for this record. *Document errors are to be returned to the source for correction. *Document non-conformances to the product record per the proper guideline. Preferred qualifications: *Minimum 1 year of experience working in a federally regulated industry. *Experience reviewing medical device records preferred. *High school diploma or successful completion of GED. *Diligence must be maintained in records review in spite of the repetition of required tasks; adherence to the checklist reference. *Understand the operation of the area and the requirements of the support function. *Has demonstrated, and will continue to demonstrate, consistent accuracy. *Good working knowledge of basic math. *Exceptional attention to detail. *Communicate professionally and work cooperatively with others. *Team player, willing to be flexible in areas of responsibility. *Willing to learn, suggest improvements, and train others. *A willingness to adapt and flow with the work pace and changes that come with this assignment. Manpower associates on assignment have access to a great benefit package including weekly paychecks, an insurance program, anniversary/holiday pay, training opportunities, direct deposit/paycard, tuition/certification reimbursement, and much more! Apply today or give us a call for more information: 734-665-3757 (Ann Arbor) or 734-241-2040 (Monroe). Want to get a head start? Go to www.manpowerjobs.com to create a "My Manpower" account, and then give us a call. Manpower, Inc. of SE Michigan has helped both companies and individuals navigate the ever-changing world of work in Washtenaw and Monroe Counties for over 50 years. To learn more, visit us at: http://www.manpowermi.com. Use social media? Like us! Follow us! *On Twitter: https://twitter.com/Manpowerincsemi *On Facebook: http://www.facebook.com/ManpowerIncofSEMich *On LinkedIn: http://www.linkedin.com/company/manpower-inc.-of-se-michigan *On Pinterest: http://www.pinterest.com/manpowerincsemi/ *On Instagram: http://instagram.com/manpowerincofsemi/ Know of others looking for work? Share this post! We reward those who refer successful associates. Ask us about our referral program. Manpower, Inc. of SE Michigan is an Equal Opportunity Employer.