General Job Duties:

• Quality Management & Compliance: Operates under the direction of the Director of Quality Operations to ensure compliance with our client's GMP Quality Management System program.

• Leadership & Communication: Serves as the backup for the Director of Quality Operations and maintains open communication through regular reports, memos, and meetings.

• Technical Representation: Acts as the Calibration Laboratory Management Representative for our client.

• Regulatory Oversight: Manages and ensures our client's Quality Management System remains compliant with a comprehensive range of standards, including ISO 9001, MDSAP (ISO 13485, TG(MD)R Sch3, RDC ANVISA 665/2022, CMDR, Japan MHLW Ministerial Ordinance No. 169, FDA (21 CFR 820)), FDB, CA-RHB (product registrations, compliance, & licensing), NRC, BIS, DOT 49 CFR / IAEA, DAkkS / ISO 17025, and CE Mark requirements under the Medical Device Directive (93/42/EEC) and Medical Device Regulation (EU 2017/745).

• Training and Development: Manages and conducts cGMP and employee training programs. Maintains and supports additional required quality systems and compliance initiatives.

• Key Program Management: Oversees and manages the Regulatory Compliance Program, the Corrective Action & Prevention Action (CAPA) Program, and the Internal Audit Program.

• Auditing and Remediation: Conducts internal and supplier audits, prepares detailed audit reports, issues CAPAs, and provides training to internal auditors.

• Regulatory Submissions: Conducts necessary regulatory reviews and submits product registrations for NRC/CA-RHB SS&DRs, CMDR licenses, RMLs, FDA, MDD/MDR, import/export control, and other applicable regulatory bodies.

• Licensing and Agency Contact: Conducts customer license reviews, applies for export licenses from BIS and NRC as needed, and serves as a point of contact for regulatory agencies and customers.

• Product Documentation: Supports compliance for Special Form Radioactive Materials and assists in the approval of capsule/package test report documentation and certificates.

• Documentation Control: Oversees and manages our client's Document Management Program, including the revision process for procedures to maintain Quality Control and Quality Assurance. Holds final approval authority for all controlled procedures, procedure revisions, Engineering Drawings, and Engineering Change Orders. Supports all documentation control activities.

• Customer Feedback Management: Responsible for the Customer Complaints and Returns program, including evaluating complaints (with input from Sales), assisting in the returned sources program maintenance, and providing final approval on Complaints and Returns reports.

• Audit Support: Assists in scheduling, participating in, following up on, or leading audits as necessary.

• Team Leadership & Management:

  • Manages the company-wide training program by formulating and conducting Quality and Regulatory training.

  • Participates in the interview process and provides hiring recommendations to upper management.

  • Plans, assigns, and directs departmental work.

  • Establishes and monitors department goals and objectives.

  • Trains, motivates, evaluates, rewards, and disciplines employees, including conducting performance appraisals and resolving complaints.

• Travel: Requires travel to the Burbank and Valencia facilities, as well as for supplier audits and training.

• Other Duties: Performs additional management-required duties as assigned.

Requirements:

1. Education: Bachelor’s degree or equivalent in a scientific related field is the minimum requirement.

2. Experience:

   • Minimum of 5 years of relevant experience in medical devices or pharmaceuticals, with a preference for Regulatory Affairs or a related quality field.

   • Minimum of 5 years of experience managing direct reports.

   • Minimum of 5 years of experience preparing regulatory submissions, including, but not limited to, product registrations and customer licensing for the FDA, EU MDR, and other international markets.

3. Specialized Skills and Knowledge:

   • Certified Lead Auditor status.

   • Must be able to travel to and work at the Burbank and Valencia sites.

   • Demonstrated experience with compliance to key regulatory frameworks, including MDSAP, European Medical Device Directives (MDD), EU MDR/IVD, FDA QSR/QMSR, and various ISO standards.

   • Proven history of successful regulatory submissions.

   • Proficiency in documentation and records administration.

   • Experience handling customer complaints and providing excellent customer service.

   • Exceptional communication skills (written, verbal, phone, video conference) for effective interaction with various clients and regulatory agencies.

   • Strong interpersonal skills for effective communication across all organizational levels.

   • Excellent problem-solving, prioritizing, and time management abilities.

   • Demonstrated ability to lead and conduct internal, supplier, and customer audits.

   • Strong attention to detail.

   • Experience in design control, manufacturing, process development, quality assurance, and quality control.

   • Ability to work both independently and collaboratively in a team setting.

   • Excellent planning, organization, and flexibility to adapt to a fast-paced and changing environment.

   • Proficiency with Microsoft Dynamics or a comparable ERP system, Microsoft Office Suite (Word, Excel, PowerPoint), Teams, SharePoint, and a flowcharting program (e.g., SmartDraw).

   • Physical ability to lift up to 50 lbs.