Quality Assurance and Regulatory Compliance Specialist II

2 weeks ago

Saco, Maine, United States MMQCI Full time
Position Overview:
The Quality Assurance and Regulatory Affairs (QA/RA) Specialist II plays a crucial role in ensuring adherence to quality standards and regulatory compliance within the organization. This position involves conducting audits, reviewing documentation, and analyzing data to maintain the integrity of the quality management system.

Company Background:
Maine Molecular Quality Controls, Inc. (MMQCI) is dedicated to the design, development, and manufacturing of innovative quality control products utilized by clinical laboratories. Our focus is on enhancing the accuracy of diagnostic tests across various medical fields, including genetics, oncology, and infectious diseases.

Key Responsibilities:
  1. Evaluate and authorize all quality system documentation to ensure compliance with established protocols and regulatory standards, including Master Batch Records, Standard Operating Procedures (SOPs), and Corrective and Preventive Actions (CAPAs).
  2. Conduct reviews and approvals for validations related to new equipment and processes.
  3. Assist in or conduct internal and supplier audits.
  4. Support regulatory audits conducted by FDA and customers.
  5. Compile Device Master Records for new product offerings.
  6. Oversee training documentation for all personnel within the organization.
  7. Maintain ISO 13485 certification and contribute to Technical Files for CE marking, as well as manage international product registrations.
  8. Prepare and submit FDA pre-submissions, de novo requests, and 510(k) submissions for Class II products, ensuring compliance with regulatory requirements.
  9. Interpret and communicate relevant statutes, regulations, and guidance to staff, highlighting their implications for product development and manufacturing processes.
  10. Stay informed on regulatory trends affecting products and relay pertinent information to QA/RA teams and product development groups.
  11. Participate in and potentially lead internal, customer, FDA, and ISO audits.
  12. Collaborate with QA/RA and other departments to review and approve product labeling changes and marketing materials.
  13. Deliver training sessions on various regulatory topics to cross-functional teams.
  14. Draft SOPs and provide training to key personnel as necessary.
  15. Perform additional duties as assigned, including monitoring and enhancing the quality system and managing post-market surveillance and reporting.
Qualifications:
  1. Bachelor's degree in Life Sciences with a minimum of 5 years of experience in a cGMP regulated environment and at least 2 years in Quality Assurance.
  2. Strong proofreading and attention to detail skills.
  3. In-depth knowledge of current GMP regulations.
  4. Familiarity with ISO 13485 and In Vitro Diagnostic Regulation (IVDR).
  5. Experience in laboratory medicine is highly desirable.
  6. Excellent written and verbal communication skills, along with proficiency in computer applications including Excel.
  7. Ability to manage multiple tasks in a fast-paced environment with shifting priorities.
  8. Demonstrated strong work ethic and ability to meet tight deadlines.
  9. Willingness to learn and contribute as part of a collaborative team.
  10. Ability to provide constructive feedback to address non-conforming practices.
  11. Must adhere to non-smoking policies to prevent product contamination.
Benefits:
• Comprehensive medical and dental insurance
• 401(k) plan
• Profit-sharing opportunities
• Paid vacation and holidays
• Sick leave provisions

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