Quality Assurance & Regulatory Affairs Manager

JOB PURPOSE:

Coordinate the development and administration of the company’s quality assurance (QA) and regulatory affairs (RA) throughout the organization, in accordance with customer, company and regulatory requirements. Responsible for establishing quality assurance policies and procedures as they relate to ISO 13485:2016 and FDA 21 CFR Part 820 and other related regulations. This position is accountable for managing, planning, organizing, directing, and controlling a Quality Assurance Program which includes quality control, quality engineering, and product safety functions to ensure customer requirements are satisfied. The position must provide management controls and ensure regulatory compliance requirements are met for all products produced at Xeridiem and maintain the quality system to ensure compliance.

ESSENTIAL DUTIES:

· Serve as site Management Representative, ensuring the QMS complies with all Serve as site Management Representative, ensuring the QMS complies with all applicable standards and fostering a quality-focused culture.

· Lead the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with ISO 13485, FDA QSR, and global regulatory expectations.

· Direct internal and external audits (FDA, ISO, customer, notified body), manage responses to findings, and drive CAPA closure and systemic improvements.

· Oversee all QMS subsystems including document control, change management, nonconformance handling, training, supplier quality, and product release.

· Drive continuous improvement initiatives, leveraging tools such as FMEA, Root Cause Analysis, SPC, Lean/Six Sigma, and Kaizen to enhance product quality and operational performance.

· Lead efforts to identify and reduce Cost of Poor Quality (COPQ) through proactive risk identification, process standardization, scrap reduction and preventive action.

· Implement or enhance quality automation and digital transformation initiatives across QMS functions to increase process efficiency and data visibility.

· Monitor and report on key performance indicators (KPIs), quality trends, and management review data to inform leadership decisions.

· Provide quality oversight for new product development, validations, and design transfer to manufacturing, ensuring quality and regulatory integration from concept through commercialization.

· Oversee supplier qualification, performance monitoring, and resolution of supplier-related quality issues through effective collaboration and audit programs.

· Supervise, mentor, and develop a team of quality engineers, inspectors, and specialists, including goal setting, coaching, and performance management.

· Act as the site’s Person Responsible for Regulatory Compliance (PRRC) as required by EU MDR 2017/745 and internal policy.

· Provide regulatory strategies and guidance to cross-functional teams throughout the product lifecycle, including design control, labeling, and post-market activities.

· Prepare, review, and submit domestic and international regulatory submissions (e.g., 510(k), CE Technical Files, renewals, amendments).

· Maintain and update technical documentation, registrations, and licenses to ensure regulatory compliance for all commercialized products.

· Interface with regulatory authorities, including the FDA, Notified Bodies, and other global agencies, to support product submissions, inspection readiness, and response coordination.

· Monitor and communicate changes in global regulatory requirements, standards, and guidance documents; implement updates to internal procedures and documentation accordingly.

· Support post-market surveillance activities, including adverse event reporting, complaint trending, and field action documentation.

QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities)

Required:

· Bachelor’s degree in scientific or engineering discipline (e.g., biomedical, mechanical, chemical, industrial engineering); equivalent experience considered.

· Minimum 5–7 years of experience in Quality Assurance leadership in a regulated industry, with experience managing Regulatory Affairs.

· Minimum 2 years of people management or supervisory experience, including direct reports, mentoring, and team development.

· Deep understanding of ISO 13485, FDA 21 CFR Part 820, and EU MDR; familiarity with global regulatory frameworks and submission processes.

· Demonstrated success in managing audits, Inspections, CAPA systems, product quality investigations, and QMS improvements.

· Experience with electronic QMS (eQMS) platforms and document management systems.

· Proficient in Microsoft Office Suite and quality/regulatory systems; skilled in data analysis, reporting, and dashboard development.

· Strong communication, leadership, and cross-functional collaboration skills.

· Responsible for understanding and complying with all SPG and Dupont safety policies and procedures.

Preferred:

· Certifications such as RAC, CQE, CQA, CMQ/OE, or Six Sigma Green/Black Belt.

· Experience leading continuous improvement, COPQ reduction, and quality automation or digital transformation initiatives.

· Prior success in global regulatory submissions and product launch support, especially for Class II/III medical devices or combination products.

· Familiarity with Lean Manufacturing and operational excellence methodologies.

WORKING CONDITIONS:

Works under general supervision. Light physical activity with the majority of time spent standing and working on manufacturing line where protective clothing is required. Position requires flexible hours and ability to work around chemicals.