Chief Quality & Regulatory Affairs Leader

Jadex; Greer (SC); On-site; USD 170,000 - 230,000; Full time

Job summary

Alltrista Plastics LLC, a Jadex Inc. subsidiary, is seeking a Director of Quality Systems & Regulatory Affairs in Greer, SC. This leadership role oversees regulatory compliance, QMS implementation, and cross-functional collaboration to ensure safe, compliant medical devices across global markets.

The ideal candidate has 10+ years in QA/Regulatory Affairs for medical devices, with strong FDA and ISO knowledge, strategic vision, and ability to mentor teams and drive continuous improvement.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related field (Master’s 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.
• Strong leadership, communication, and interpersonal skills.
• Ability to work collaboratively in a team environment and manage multiple projects.

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 regulatory agencies and manage 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 standards.
• Conduct regular audits and inspections to ensure compliance with quality system requirements and address non-conformities.
• Lead risk management activities throughout the product lifecycle, including risk assessments and post-market surveillance.
• Ensure product-related complaints are investigated and reported to regulatory authorities in a timely manner.
• Develop and deliver training programs for employees on quality standards and regulatory requirements.
• Collaborate with R&D, manufacturing, and marketing to ensure compliance throughout product development and commercialization.
• Drive continuous improvement in quality processes, metrics, and product quality outcomes.
• Analyze data to identify trends and generate reports for leadership.

Skills

Leadership

Regulatory affairs

Quality Assurance

FDA regulations

ISO standards

Project management

Communication

Education

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

Master’s degree preferred

Job description

Alltrista Plastics LLC, a Jadex Inc. subsidiary, is seeking a Director of Quality Systems & Regulatory Affairs in Greer, SC. This leadership role oversees regulatory compliance, QMS implementation, and cross-functional collaboration to ensure safe, compliant medical devices across global markets.

The ideal candidate has 10+ years in QA/Regulatory Affairs for medical devices, with strong FDA and ISO knowledge, strategic vision, and ability to mentor teams and drive continuous improvement.