Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Position Title: Quality Assurance/Regulatory Affairs Specialist II
Employer: Maine Molecular Quality Controls, Inc. (MMQCI) designs, develops, manufactures, and markets unique quality control products used by hospital laboratories to monitor the accuracy of tests for inherited disease, pharmacogenetics, oncology, and infectious diseases. MMQCI has developed technologies to stabilize DNA and RNA for use as quality controls and continues to pursue the discovery of novel techniques useful for the development of new quality control products. We are a small, growing company that offers a relaxed but challenging work environment.
BENEFITS:
Please apply through Email/ No Phone inquiries accepted at this time.
GENERAL SUMMARY:
The Quality Assurance/Regulatory Affairs (QA/RA) Specialist II is responsible for all activities involving quality assurance and compliance with applicable regulatory requirements. Under the supervision of the Manager of QA/RA, the QA/RA Specialist II is responsible for implementation, management, and maintenance of policies, procedures, and systems that ensure quality compliance to MMQCI’s Quality System, based on federal Quality System Regulation 21CFR820, ISO 13485, and IVDR. The successful candidate has a strong in vitro laboratory diagnostic industry background and is experienced in global regulatory submissions, and registrations. It is expected that the QA/RA Specialist II will rapidly develop sufficient expertise to function independently. Maine Molecular is looking for the person with the energy and experience to step into this vital position in a growing company and grow along with us.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
A cover letter is required.
Contact Information:
Human Resources
Maine Molecular Quality Controls, Inc.
23 Mill Brook Road
Saco, Maine 04072
LOCATION: MMQCI is conveniently located in beautiful southern coastal Maine, minutes from the Maine Turnpike, Portland International Jetport, and less than 2 hours from Boston. Close by are fabulous Portland restaurants, sandy beaches, and a plentiful supply of Maine lobsters! Many terrific outdoor activities are easily accessible including hiking, biking, kayaking, fishing, skiing and snowshoeing. We’re in a state-of-the-art facility located in Saco, right next to the Eastern Trail. Come join us!
Job Type: Full-time
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Work Location: In person
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