Alltrista - Director, Quality Systems & Regulatory Affairs

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, is a subsidiary of Jadex Inc., and is a leading manufacturer in high-volume, precision injection molded parts. The company designs and manufactures with proprietary engineering processes and extensive manufacturing capabilities, from five (5) locations worldwide. From the first spark of an idea, through the design of the mold to the actual manufactured product, Alltrista Plastics focuses all efforts on delivering innovative plastic solutions. The company’s core markets include Consumer Products, Medical/Healthcare, Personal Care, Health & Beauty, Caps & Closures, and Packaging.

The Director of Quality Systems and Regulatory Affairs will be responsible for ensuring compliance with regulatory requirements, maintaining robust quality management systems, and guiding product development processes across the organization. This role requires a strategic leader who can navigate complex regulations and drive a culture of quality excellence.

Primary Functions

• 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 proactively address non-conformities.
• Lead risk management activities throughout the product lifecycle, including risk assessments, mitigation strategies, and post-market surveillance.
• Ensure that product-related complaints are investigated and resolved in a timely manner, with appropriate reporting to regulatory authorities.
• Develop and execute training programs for employees regarding quality standards, regulatory requirements, and best practices.
• Collaborate with cross-functional teams, including R&D, manufacturing, and marketing, to ensure compliance throughout all phases of product development and commercialization.
• Drive initiatives for continuous improvement in quality processes, metrics, and product quality outcomes.
• Analyze data to identify trends, make informed decisions, and generate reports for leadership review.

Key Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a 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.
• Strong leadership, communication, and interpersonal skills.
• Ability to work collaboratively in a team-oriented environment and manage multiple projects simultaneously.
• Demonstrated ability to influence across functions and lead through collaboration rather than direct authority.
• Strong analytical, communication, and leadership skills.
• Experience supporting senior leadership and driving business performance through financial insights.

Jadex Inc and its Businesses do not discriminate in employment based on race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.