Strategic Director, Quality Systems & Regulatory Affairs

Alltrista Plastics LLC; Greer (SC); On-site; USD 150,000 - 210,000; Full time

Job summary

Alltrista Plastics LLC seeks a Director of Quality Systems and Regulatory Affairs to lead regulatory strategy and quality management across the organization. You will oversee the development, implementation, and maintenance of the QMS, coordinate submissions (FDA, PMA/510(k), CE), audits, and continuous improvement to drive product excellence.

This role requires 10+ years in medical device QA/RA, strong leadership, and cross-functional collaboration with R&D, manufacturing, and marketing to

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• Master’s degree preferred.
• A minimum of 10 years experience in Quality Assurance and Regulatory Affairs within the medical device industry.
• In-depth knowledge of FDA regulations, ISO standards, and other international regulatory requirements applicable to medical devices.
• Proven experience in leading regulatory submissions and quality system audits.

Responsibilities

• Develop and implement quality and regulatory strategies aligned with corporate objectives and regulatory requirements.
• Lead and mentor the Quality Systems and Regulatory Affairs team, fostering a culture of compliance, continuous improvement, and accountability.
• Serve as the primary point of contact for all regulatory agencies and manage communications regarding submissions, inspections, and inquiries.
• Prepare and submit necessary regulatory filings (e.g., 510(k), PMA, CE Mark) to obtain and maintain product approvals across global markets.
• Oversee the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with ISO 13485, FDA regulations, and other relevant standards.
• Conduct regular audits and inspections to ensure compliance with quality system requirements and address non-conformities.

Skills

Leadership

Regulatory affairs

Quality management

FDA regulations

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Life Sciences

Master's degree preferred

Job description

Alltrista Plastics LLC seeks a Director of Quality Systems and Regulatory Affairs to lead regulatory strategy and quality management across the organization. You will oversee the development, implementation, and maintenance of the QMS, coordinate submissions (FDA, PMA/510(k), CE), audits, and continuous improvement to drive product excellence.

This role requires 10+ years in medical device QA/RA, strong leadership, and cross-functional collaboration with R&D, manufacturing, and marketing to