Alltrista - Director, Quality Systems & Regulatory Affairs

Jadex; Greer (SC); Presencial; USD 170.000 - 230.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Leadership

Regulatory affairs

Quality Assurance

FDA regulations

ISO standards

Project management

Communication

Educación

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

Master’s degree preferred

Descripción del empleo

Alltrista - Director, Quality Systems & Regulatory Affairs

Greer, SC, USA

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.