Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (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