Senior Director, Quality Systems & Regulatory Affairs

Alltrista Plastics LLC; Greer, Northern (SC, KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Alltrista Plastics LLC in Greer, SC, USA seeks a Director of Quality Systems and Regulatory Affairs to lead global regulatory strategy and QMS implementation. You will drive compliance with FDA regulations, ISO 13485, and product lifecycle governance across R&D, manufacturing, and operations.

The role requires a strategic leader with 10+ years in medical device QA/RA, proven submissions experience, and strong cross-functional collaboration to sustain quality excellence.

Qualifications

• 10+ years in QA and regulatory affairs within the medical device industry.
• Deep knowledge of FDA regulations, ISO standards, and global regulatory requirements.
• Experience leading regulatory submissions and quality system audits.
• Strong leadership and cross-functional collaboration.
• Proven ability to translate regulatory requirements into product development.

Responsibilities

• Develop and implement quality and regulatory strategies aligned with corporate objectives.
• Lead the Quality Systems and Regulatory Affairs team and drive continuous improvements.
• Serve as primary contact for regulatory agencies and manage submissions, inspections, and inquiries.
• Prepare regulatory filings (e.g., 510(k), PMA, CE Mark) for global markets.
• Oversee QMS development and maintenance in line with ISO 13485 and FDA regulations.
• Conduct audits and inspections to ensure compliance and address non-conformities.
• Lead risk management across product lifecycles with mitigation and post-market surveillance.
• Investigate and report product complaints to regulatory authorities.
• Develop training programs on quality standards and regulatory requirements.
• Collaborate with R&D, manufacturing, and marketing to ensure regulatory compliance.
• Drive continuous improvement in quality processes and metrics.
• Analyze data, identify trends, and report to leadership.

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Master’s degree preferred

Job description

Alltrista Plastics LLC in Greer, SC, USA seeks a Director of Quality Systems and Regulatory Affairs to lead global regulatory strategy and QMS implementation. You will drive compliance with FDA regulations, ISO 13485, and product lifecycle governance across R&D, manufacturing, and operations.

The role requires a strategic leader with 10+ years in medical device QA/RA, proven submissions experience, and strong cross-functional collaboration to sustain quality excellence.