Quality Assurance/Regulatory Affairs Specialist II - MMQCI

1. Reviews and approves all MMQCI Quality System documentation to ensure compliance with established procedures and regulatory compliance requirements, including, but not limited to, Master Batch Records, Standard Operating Procedures (SOPs), Change Orders, Material Review Notices (MRNs) and Corrective and Preventive Actions (CAPAs). Works closely with all departments to investigate MRNs and establish CAPAs addressing root cause.
2. Reviews and approves validations of new equipment and processes.
3. Assists or performs internal audits and supplier audits.
4. Supports FDA and customer audits.
5. Assembles Device Master Records for new products.
6. Oversees training documentation of all MMQCI employees.
7. Maintains MMQCI’s ISO 13485 certification and prepares input into Technical Files for CE marking of MMQCI products and maintains international product registrations.
8. Prepares and submits FDA pre-submissions, de novo requests, and 510(k) submissions for MMQCI’s Class II products and maintains appropriate FDA registrations.
9. Interprets statutes, regulations, policies and guidance for MMQCI staff teams, communicating how these impact product development and Design Control, manufacturing, and/or marketing.
10. Remains current on regulatory issues/trends affecting MMQCI products, assessing and communicating their impact to QA/RA colleagues and product development/support teams.  
11. Participates in, and may conduct, internal, customer, FDA, and ISO audits.
12. Works closely with QA/ RA and other MMQCI staff to review and approve product labeling changes, promotional literature and marketing materials, rework of non-conforming product, CAPA closures, Customer Complaint closures, and Medical Device Reports (MDR).
13. Provides training or presentations to cross-functional groups on a variety of regulatory topics.
14. Writes SOPs and trains key personnel as needed.
15. Perform other duties as assigned, including but not limited to, help monitor, maintain, and improve the quality system and serve as the person responsible for post-market surveillance, reporting and recalls.

1. Education Requirements: Bachelor of Science degree in Life Sciences and at least 5 years of employment in a cGMP regulated facility and at least 2 years of experience in Quality Assurance.
2. Excellent proof-reading skills are required.
3. Knowledge of current GMP regulations is required.
4. Very detail oriented.
5. Knowledge of ISO 13485 is required.
6. Knowledge of In Vitro Diagnostic Regulation (IVDR) is required.
7. Experience in laboratory medicine is highly preferred.
8. Good communication skills, written and oral, with excellent computer skills including Excel.
9. Ability to multi-task in a dynamic environment with changing priorities.
10. Strong work ethic.
11. Ability to meet challenging timelines, in spite of obstacles.
12. Willingness to learn and pitch in as part of team
13. Ability to communicate clearly and constructively to correct non-conforming behaviors and practices.
14. Must be a nonsmoker due to product contamination prevention requirements.

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