Senior Director, Quality & Regulatory (Med Devices)

Jadex Inc.; Greer (SC); On-site; USD 180,000 - 240,000; Full time

Job summary

Alltrista Plastics LLC, a Jadex Inc. subsidiary, seeks a Director of Quality Systems and Regulatory Affairs to lead regulatory strategy, QMS implementation, and compliance across global markets.

You will mentor the QSR team, serve as primary liaison with regulatory agencies, oversee submissions (510(k), PMA, CE marking), and drive continuous improvement. The role requires strategic leadership and deep medical device QA/RA experience.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• Master’s degree preferred.
• Minimum 10 years experience in Quality Assurance and Regulatory Affairs within the medical device industry.
• In-depth knowledge of FDA regulations, ISO standards, and international regulatory requirements for medical devices.
• Proven experience leading regulatory submissions and quality system audits.
• Strong leadership, communication, and interpersonal skills.
• Ability to lead across functions and drive collaboration.
• Experience supporting senior leadership with financial insights.

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 compliance and continuous improvement.
• Serve as the primary contact for regulatory agencies and manage communications regarding submissions, inspections, and inquiries.
• Prepare and submit 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 QMS in compliance with ISO 13485, FDA regulations, and other standards.
• Conduct regular audits and inspections to ensure QMS compliance and address non-conformities.
• Lead risk management activities across the product lifecycle, including assessments and post-market surveillance.
• Ensure timely investigation and resolution of product-related complaints with regulatory reporting.
• Develop and execute training programs 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 and product outcomes.
• Analyze data to identify trends and generate leadership reports.

Skills

Regulatory leadership

Quality systems

FDA regulations

ISO standards

Regulatory submissions

Audits

Cross-functional leadership

Risk management

Data-driven decision making

Communication skills

Education

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

Master’s degree preferred

Job description

Alltrista Plastics LLC, a Jadex Inc. subsidiary, seeks a Director of Quality Systems and Regulatory Affairs to lead regulatory strategy, QMS implementation, and compliance across global markets.

You will mentor the QSR team, serve as primary liaison with regulatory agencies, oversee submissions (510(k), PMA, CE marking), and drive continuous improvement. The role requires strategic leadership and deep medical device QA/RA experience.