Director of Quality and Regulatory Affairs

Lead Quality & Regulatory Excellence – Join PRC Saltillo as Director of Quality and Regulatory Affairs!

At PRC Saltillo, quality and compliance are foundational to our mission—and we’re seeking an experienced Director of Quality and Regulatory Affairs to provide strategic leadership across our organization. In this role, you’ll oversee all aspects of quality assurance and regulatory affairs, ensuring our products meet global regulatory requirements and quality standards throughout their entire lifecycle, from design and development through manufacturing and post market performance.

As a key leader, you’ll guide quality strategy, lead and mentor a high performing team, partner cross functionally with Engineering, Operations, and Procurement, and ensure ongoing compliance with FDA/QMSR, ISO, EUMDR, and other applicable standards. If you’re a collaborative leader with deep regulatory expertise and a passion for continuous improvement, this is an opportunity to make a lasting impact.

Go to our website to apply https://prentkeromich.bamboohr.com/careers

Why You’ll Love Working Here

• Mission Driven Leadership: Shape quality and regulatory strategy that supports products improving lives.
• Strategic Impact: Lead company wide quality and regulatory initiatives with direct organizational influence.
• Collaborative Culture: Partner with cross functional teams to drive innovation, compliance, and excellence.
• Continuous Improvement Focus: Champion systems and processes that strengthen quality, performance, and compliance.

Duties and Responsibilities

• Ensure a robust and compliant quality management system (QMS) aligned with ISO 13485, FDA/QMSR, EUMDR, and other applicable standards.
• Provide leadership and oversight to personnel serving as primary contacts for external audits, assessments, and inspections, ensuring ongoing audit readiness.
• Lead management review processes and ensure effective follow up on quality system performance and improvement initiatives.
• Oversee interpretation and implementation of regulatory, legal, customer, and industry quality requirements.
• Ensure effective and compliant training programs for employees at all levels on quality standards, procedures, and continuous improvement methodologies.

Education and Experience

• Bachelor’s degree in Engineering, Quality Management, Compliance, or a related field required.
• Minimum of five years of experience in regulatory affairs and quality management systems within medical devices or related industries required.
• At least three years of experience working with a document control system required.

Required Skills/Abilities

• Demonstrated leadership and coaching skills with the ability to build and sustain a team-oriented culture.
• Strong analytical, organizational, and problem-solving skills.
• Advanced proficiency in Microsoft Office, particularly Excel, with the ability to analyze and present large datasets.
• Ability to effectively delegate, prioritize, and coordinate a wide variety of activities.
• In depth knowledge of medical device manufacturing compliance, quality systems, procurement, and shipping requirements.
• Strong relationship building skills with clients, colleagues, and vendors/suppliers.
• Excellent written, verbal, and interpersonal communication skills.
• Self-directed with the ability to perform effectively with minimal supervision.
• Collaborative team player able to work across all levels of the organization.
• Adaptable and flexible in a dynamic, evolving environment.