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Quality Assurance and Regulatory Compliance Specialist II

2 months ago

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

Key Responsibilities:
  1. Review and authorize all quality system documentation to guarantee compliance with established protocols and regulatory requirements, including Master Batch Records, Standard Operating Procedures (SOPs), Change Orders, Material Review Notices (MRNs), and Corrective and Preventive Actions (CAPAs). Collaborate with various departments to investigate MRNs and implement CAPAs addressing root causes.
  2. Evaluate and approve validations for new equipment and processes.
  3. Assist in or conduct internal and supplier audits.
  4. Support audits conducted by regulatory bodies and clients.
  5. Compile Device Master Records for new product offerings.
  6. Oversee training documentation for all employees.
  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 proper FDA registrations are maintained.
  9. Interpret relevant statutes, regulations, and guidance for staff, clarifying their implications for product development, manufacturing, and marketing.
  10. Stay informed on regulatory trends affecting products, assessing and communicating their implications to QA/RA colleagues and product development teams.
  11. Participate in and may lead internal, customer, FDA, and ISO audits.
  12. Collaborate with QA/RA and other staff to review and approve product labeling changes, promotional materials, non-conforming product rework, CAPA closures, customer complaint resolutions, and Medical Device Reports (MDR).
  13. Provide training or presentations 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 overseeing post-market surveillance, reporting, and recalls.
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. Exceptional proofreading skills.
  3. In-depth knowledge of current GMP regulations.
  4. Meticulous attention to detail.
  5. Familiarity with ISO 13485 standards.
  6. Understanding of In Vitro Diagnostic Regulation (IVDR).
  7. Experience in laboratory medicine is highly desirable.
  8. Strong written and verbal communication skills, along with proficiency in computer applications including Excel.
  9. Able to manage multiple tasks in a dynamic setting with shifting priorities.
  10. Demonstrated strong work ethic.
  11. Capability to meet demanding timelines despite challenges.
  12. Willingness to learn and contribute as part of a team.
  13. Ability to communicate effectively to address non-conforming behaviors and practices.
  14. Must be a non-smoker due to contamination prevention protocols.
Benefits:
• Medical insurance
• Dental insurance
• 401(k) plan
• Profit-sharing opportunities
• Paid vacation
• Paid holidays
• Sick leave