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 seeking to add a Regulatory Affairs and Quality Assurance (QA/RA) Specialist II to our growing team, who will be a key team member in ensuring compliance with applicable regulatory requirements and quality assurance standards. This is a great opportunity to join a team where your contributions will be critical to the successful launch and ongoing regulatory affairs and compliance work of new and existing molecular diagnostic devices. We’re specifically looking for an individual with a strong in vitro laboratory diagnostic industry background, especially in using and maintaining a Quality System specific to regulated medical devices. MMQCI values learning and growth and has a team and culture where you can have a significant impact in this role.

What you will get to do:

• Work closely with the Manager of QA/RA across a spectrum of regulatory and quality processes
• Prepare and submit FDA pre-submissions, de novo requests, and 510(k) submissions for MMQCI’s Class II products and maintain appropriate FDA registrations
• Prepare input for MMQCI product regulatory submissions (global) such as Technical Files for CE marking and maintain international product registrations
• Interpret statutes, regulations, policies and guidance for MMQCI staff teams, and communicate how these impact product development and Design Control, manufacturing, and/or marketing
• Provide training to cross-functional groups on a variety of regulatory topics.
• Work closely with QA/RA staff to review, approve and maintain MMQCI ISO 13485 Quality System documentation to ensure compliance with established procedures and regulatory requirements
• Conduct Quality System audits related to ISO 13485 and applicable global regulatory requirements

Required Experience:

• Bachelor of Science degree in Life Sciences and at least 5 years of direct experience in a cGMP regulated facility
• At least 2 years of experience in Quality Assurance
• Knowledge of and experience with ISO 13485 and GMP regulations is required.
• Knowledge of and experience with In Vitro Diagnostic Regulation (IVDR) is required
• Experience in laboratory medicine is highly preferred
• Must be a nonsmoker due to product contamination prevention requirements

Skills:

• Excellent proofreading skills are required
• Good communication skills, written and oral, with strong Microsoft product knowledge
• Ability to multi-task in a dynamic environment with changing priorities
• Ability to meet challenging timelines, despite obstacles
• Strong work ethic and willingness to learn as a team

• Work closely with the Manager of QA/RA across a spectrum of regulatory and quality processes
• Prepare and submit FDA pre-submissions, de novo requests, and 510(k) submissions for MMQCI’s Class II products and maintain appropriate FDA registrations
• Prepare input for MMQCI product regulatory submissions (global) such as Technical Files for CE marking and maintain international product registrations
• Interpret statutes, regulations, policies and guidance for MMQCI staff teams, and communicate how these impact product development and Design Control, manufacturing, and/or marketing
• Provide training to cross-functional groups on a variety of regulatory topics.
• Work closely with QA/RA staff to review, approve and maintain MMQCI ISO 13485 Quality System documentation to ensure compliance with established procedures and regulatory requirements
• Conduct Quality System audits related to ISO 13485 and applicable global regulatory requirement