STERIMED US is the American operation of the Sterimed Group, a global leader in sterile barrier systems and integrated medical packaging solutions serving the medical device, pharmaceutical, and life sciences industries.

We combine global expertise with local responsiveness to help customers protect product integrity, simplify supply chains, and support regulatory compliance. Our expanding capabilities include ISO Class 7 and 8 cleanroom assembly and packaging, contract manufacturing, Form-Fill-Seal packaging, ultrasonic cleaning, kitting, sterilization management, and comprehensive packaging solutions tailored to the evolving needs of the medical device and life sciences industries.

As we continue to invest in new cleanroom facilities, advanced manufacturing technologies, and value-added services across the United States, we're building a team passionate about innovation, quality, and operational excellence. If you're looking to make a meaningful impact in a fast-growing organization backed by a global leader, we'd love to hear from you.

Summary of position

The Quality & Regulatory affair Manager is responsible for leading quality management system execution, FDA QMSR / 21 CFR Part 820 and ISO 13485 compliance, validation activities, and implement regulatory compliance strategies within medical device and sterile barrier packaging environment. This role supports the development, transfer, validation, and scale-up of manufacturing and contract packaging processes while ensuring compliance with FDA, ISO 13485, cGMP, and Sterimed Quality System requirements.

 
This position serves as a cross-functional leader between Quality, Operations, Production Planning, Engineering, Sales, Regulatory, and site leadership to convert business and technical requirements into compliant, validated, and production-ready processes. The role is responsible for quality oversight, process documentation, validation documentation, Regulatory affairs project execution (510(k) Submission), continuous improvement, and support of audits, inspections, and managementreview activities.

Your Responsibilities

• Act as Management Representative in accordance with ISO 13485 and support ongoing compliance with applicable FDA, ISO, cGMP, and regulatory requirements.
• Maintain FDA establishment registration and support regulatory documentation, audits, inspections, and technical due diligence activities.
• support the development, transfer, validation, and scale-up of manufacturing and contract packaging processes.
• Lead IQ/OQ/PQ activities in coordination with the Sterimed Group Validation Engineer and ensure new or revised processes are properly qualified before implementation.
• Develop and manage project plans, timelines, risk registers, action plans, gate reviews, and project
status updates.
• Support manufacturing and Quality Control activities related to incoming inspection, in-process
controls, final release, LHR review, efficiency improvement, and waste reduction.
• Manage NCMRs, NCRs, complaints, CAPAs, SCARs, training records, DCRs, deviations, and quality
events within the eQMS.
• Lead Quality Management Review preparation and communicate Quality, Regulatory, Validation,
Project, and Safety KPIs to site leadership.
• Support technical problem solving, root cause analysis, continuous improvement, and implementation
of corrective and preventive actions.
• Maintain strong communication with internal stakeholders including Operations, Planning, Finance,
Sales, Quality, Regulatory, and site leadership.
• Oversee the daily workflow of assigned Quality and/or project-related functions to ensure operational
excellence and compliance.
• Recruit, interview, train, develop, and evaluate assigned staff as applicable.

Your skills

• Strong knowledge of quality systems, regulated manufacturing, validation, and project management.
• Well-organized, self-directed, and able to manage multiple priorities and deadlines.
• Strong technical writing, documentation, and problem-solving skills.
• Effective leadership skills, including coaching, delegation, and team development.
• Strong cross-functional communication skills with the ability to work across Quality, Operations, Engineering, Sales, Regulatory, and leadership teams.
• Comfortable working in a fast-paced, growth-oriented, multicultural environment.
• Proficient with Microsoft Office, ERP/business systems, and eQMS or related quality software.
• Fluent in written and spoken English. Spanish and/or French is a plus.

Your qualifications

• Minimum bachelor’s degree in a scientific, technical, engineering, manufacturing, packaging, or related field; equivalent experience may be considered.
• Minimum 5 years of experience in medical device, GMP, regulated manufacturing, quality, validation, project management, or related technical operations.
• Experience with medical device quality systems, preferably in an environment with on-site manufacturing or contract packaging.
• Strong working knowledge of ISO 13485, FDA QMSR / 21 CFR Part 820, ISO 14971, validation principles, and good documentation practices.
• Direct experience supporting audits, regulatory inspections, customer audits, or quality system assessments.
• Experience with IQ/OQ/PQ, process validation, CAPA, NCMR, DCR, training, and eQMS workflows.
• Experience with project management, Gantt chart creation, and project management software.
• Preferred experience with sterile barrier systems, cleanroom packaging, pouching, tray sealing, thermoforming, medical device packaging, or contract manufacturing.
• Preferred experience supporting technology transfer, new product/process introduction, cost modeling, or CapEx justification.
• PMP certification preferred.