Manager, Regulatory Affairs And Quality Assurance

Meridian Bioscience, Inc North Billerica , MA 01862

Posted 3 months ago

Job Summary

The QA/RA Manager will implement and maintain the quality program and associated procedures to ensure overall compliance with the FDA Quality Standard Regulations (21 CFR Part 820), ISO 13485 and other local, state, and international regulations and laws, associated with maintaining a marketed medical device.

Key Duties

Essential Functions:

  • Ensure compliance with the organization's policies and all applicable national (FDA 21 CFR Part 820) and international quality standards and regulations (i.e. ISO ,CE,RoHS). Coordinate/perform complaint investigations and audits including supplier assessments.

  • Track CAPA to ensure appropriate verification, implementation and follow-up on corrective actions.

  • Work with R&D, Manufacturing and Product Support to improve product quality to meet customer requirements.

  • Lead the management of and response to site inspections conducted by federal and state authorities (e.g. FDA inspections, MA.).

  • Assist in regulatory documentation review and preparation (e.g. 510(k)s), provide regulatory strategy and guidance on new filings to R&D and Marketing, solicit and manage input from regulatory consultants.

  • Provide regulatory and process direction to manufacturing personnel, product hold coordinators and Material Review Board (MRB) to ensure compliance with Magellan's Quality System.

  • Develop and maintain QA standard operating procedures (SOP) and review SOPs generated by other departments.

  • Review and approve as needed manufacturing/test procedures (e.g. batch records and Device History Records) for products and raw materials for release into inventory and shipping.

  • Review and approve validation protocols for equipment and software testing.

  • Oversee Instrument compliance activities such as Safety, EMC, Altitude and ISTA Packaging testing.

  • Provide electrical engineering and process support to manufacturing.

  • Conduct internal audits of the quality system and conduct external audits of critical suppliers as defined by QA program.

  • Oversee the develop and maintianance of the document control process.

  • Coordinate and present at management review meetings information regarding the functioning of and impact of the quality system.

  • Develop and monitor regulatory/quality training for staff.

  • Maintain knowledge of new developments in regulatory and quality standards that would have an impact on the operations and business of Magellan Diagnostics.


Supervisory Responsibilities:

Success Factors:

  • Working knowledge of process improvement techniques.

  • Strong communication (written and verbal) and computer skills.

  • Must be able to work with minimal supervision from senior management.

  • Ability to effectively manage multiple and changing priorities.

  • Excellent ability to collaborate to achieve objectives and problem-solve.

  • Strong knowledge of ISO standards and FDA regulations/guidance as they apply to medical devices.

  • Understanding of Computer validation (FDA 21 CFR Part 11) and Equipment Validation requirements.

  • Experience in handling and coordinating responses to FDA and ISO inspections.

  • Continued education to keep up to date with changing global requirements.

Minimum Qualifications / Education:

  • BS degree in Engineering, Quality, Biology, Microbiology, or Chemistry.

  • Minimal 10+ years QA experience with a medical device manufacturer; 5+ years in a leadership role.

  • Experience in all facets of the Quality Management System a plus.

Computer Skils:

  • Proficient in Microsoft Office, Outlook.

Work Environment:

  • Lab/Office.

  • Exposure to blood.

Physical Requirements:

  • Must be able to meet National Institute for Occupational Safety & Health (NIOSH) Standards.

We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

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Manager, Regulatory Affairs And Quality Assurance

Meridian Bioscience, Inc