QA/Regulatory Leader – Medical Devices

CTL Amedica Corporation; Carrollton (TX); Hybrid; USD 110.000 - 150.000; Vollzeit

Benefits dieser Stelle

401k

Great health plans

Dental and vision coverage

Paid sick days

Holiday and vacation days

Zusammenfassung

CTL Amedica Corporation seeks an experienced Quality/Regulatory Manager to lead the QA/Regulatory staff and guide compliance across the organization. You will interpret requirements per FDA QMSR, ISO 13485:2016, and ISO 14971, and act as the primary liaison with regulatory bodies.

You will coordinate external audits, manage CAPA and non-conforming materials, and oversee product labeling, release, and post-market surveillance activities.

Qualifikationen

• Bachelor’s degree in Engineering, Life Sciences, or related technical discipline.
• 5-10 years in medical device industry; staff management preferred.
• Experience with FDA QMSR, ISO 13485:2016, ISO 14971 and interpreting device law.

Aufgaben

• Provide leadership to Quality/Regulatory staff and support activities across the organization.
• Interface with FDA, EU notified bodies, and other regulatory bodies; coordinate audits and inspections.
• Plan internal quality system audits and supplier assessments; drive CAPA activities.
• Support complaint handling and post-market surveillance activities; regulatory reporting as needed.
• Establish and maintain compliant product labeling processes and product release activities.

Kenntnisse

Quality management

Regulatory knowledge

FDA QMSR

ISO 13485

CAPA management

Staff leadership

Auditing

Post-market surveillance

Ausbildung

Bachelor’s degree in Engineering

Tools

Microsoft Office

Jobbeschreibung

POSITION SUMMARY

Responsible for providing leadership to the Quality/Regulatory staff and for supporting Quality/Regulatory activities throughout the organization. Responsible for reviewing and interpreting Quality/Regulatory requirements based on regulations and standards and providing compliance directions to the organization. The QA/RA Manager will be the primary interface with external regulatory agencies and certification/notified bodies.

DUTIES AND RESPONSIBILITIES

• Develop Quality System department goals and objectives with associated operating budget to support department activities and corporate initiatives.
• Build a strong Quality Systems team by hiring qualified candidates, establishing and actively managing performance expectations.
• Prepare and deliver training and orientations on global quality system requirements and company processes to employees.
• Interface with FDA, EU notified bodies, Authorized Representatives, certification bodies, and government agencies, as necessary to ensure currency of applicable regulatory requirements and standards. Coordinate external audits and inspections from FDA, EU notified bodies, certification bodies, and other government agencies as required. Assist with registration activities and formulate/communicate responses to audit or inspection findings.
• Plan, coordinate, and execute quality system internal audits and supplier assessment/audit activities.
• Manage Non-Conforming Material processes to appropriately disposition non-conforming product and drive corrective actions.
• Manage Corrective and Preventive Action (CAPA) activities, including investigation, implementation, and effectiveness verification.
• Support complaint handling and post-market surveillance activities, including applicable regulatory reporting.
• Establish/maintain compliant product labeling processes.
• Manage product release activities.
• Review drawing/document changes for compliance with applicable regulations and standards.
• Manage, develop, and provide leadership to Quality/Regulatory staff.
• Other duties as assigned.

ESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS

• Bachelor’s degree in Engineering, Life Sciences, or a related technical/scientific discipline.
• 5-10 years of relevant experience in the medical device industry; staff management experience preferred.
• Strong knowledge, understanding, and experience implementing FDA Quality Management System Regulation (QMSR), ISO 13485:2016, and ISO 14971. Must be able to interpret device law into workable, efficient, and effective practices and procedures.
• Experience serving as Quality System Management Representative preferred.
• Experience implementing Unique Device Identifier requirements for medical devices.
• Expertise with process/software validation, Gage R&R, and process capability preferred.
• Effective technical/leadership skills; decisive, strategic, and able to lead, motivate, and inspire others.
• Exceptional computer skills, including operation of Microsoft Office applications.
• Previous experience in the spine and/or orthopedic medical device industry preferred.

Job Status:

• Full Time, Monday through Friday

Location:

• CTL Amedica Headquarters – 2052 McKenzie Drive, Carrollton, TX 75006

Company Benefits:

• Opportunity for advancement, 401k, Great health plans, Dental and vision coverage, Paid sick days, holiday and vacation days