QA & Regulatory Affairs Leader - Medical Devices

RRD Company; Houston (TX); On-site; USD 107,000 - 171,000; Full time

Benefits offered by this job

Medical insurance

401(k) with company match

Dental and vision coverage

Paid time off

Parental leave

Tuition assistance

Job summary

RRD is seeking a Manager, Quality Assurance & Regulatory Affairs in Houston to lead and develop the site’s QMS and regulatory programs for medical devices and regulated products. The role oversees QA/RA teams and ensures compliance across ISO and FDA standards.

The position requires strong leadership, deep QA/RA expertise, and the ability to drive continuous improvement, product releases, and supplier quality agreements in a highly regulated environment.

Qualifications

• Bachelor's degree in a technical or life sciences field.
• 5+ years of related work experience including team leadership.
• 3 years medical device or pharma QA/RA experience.
• Advanced training or experience in ISO 13485:2016, ISO 14971:2019 and FDA QSR.

Responsibilities

• Maintain and continually improve the site QMS and regulatory affairs.
• Lead team of Quality Engineers, Supervisors, Specialists and Auditors.
• Lead product release for medical devices.
• Coordinate risk-based approaches to QMS and CAPAs.
• Oversee internal audits and regulatory compliance.

Skills

Leadership

Team management

Quality assurance

Regulatory affairs

Process improvement

Education

Bachelor's degree in technical or life sciences

Tools

eQMS systems

Microsoft Office

Job description

RRD is seeking a Manager, Quality Assurance & Regulatory Affairs in Houston to lead and develop the site’s QMS and regulatory programs for medical devices and regulated products. The role oversees QA/RA teams and ensures compliance across ISO and FDA standards.

The position requires strong leadership, deep QA/RA expertise, and the ability to drive continuous improvement, product releases, and supplier quality agreements in a highly regulated environment.