Quality & Regulatory Affairs Specialist

Eppendorf•Enfield, CT

1d•$70,000 - $75,000

About The Position

The Quality & Regulatory Affairs Specialist will serve as the SME for federal, state, and Canadian product regulations. You will translate changing requirements into clear actions that help our teams remain compliant and support our customers. As the regional point of contact for Quality Management and Regulatory Affairs, you coordinate requests, escalations, and cross-functional support for Sales and Service across the Americas region. You monitor and analyze federal, state, Canadian, and provincial requirements relevant to Eppendorf instruments, products, operations, waste, and gas, using regulatory databases, government websites, and other reliable sources. Through a regulatory master list and structured gap analyses, you identify new or amended requirements, assess their applicability, and coordinate follow-up with Corporate Quality, Regulatory Affairs, and R&D. You support and continuously improve the Commercial Quality Management System, including document control, change management, nonconformance management, CAPA, risk management, management review, and internal-audit activities. For audits and inspections, you prepare evidence, coordinate documentation, support ISO audits, respond to findings, and follow corrective actions through to effective closure; occasional travel to other sites may be required. You provide clear regulatory and quality documentation to customers and internal teams, act as a subject-matter expert, support device registrations and submissions, and help ensure that customer requests are handled accurately and efficiently. By delivering guidance, training, and practical support, you strengthen quality and regulatory awareness across local teams and contribute to KPI reporting, process improvements, complaint handling, post-market surveillance, and service-calibration activities where applicable.

Requirements

Bachelor’s Degree
Background in regulatory analysis and interpretation.
Ability to turn complex federal, state, Canadian, or provincial requirements into clear, actionable guidance for business and technical stakeholders.
Experience coordinating complaint handling, adverse-event reporting, field-safety corrective actions, post-market surveillance, product registrations, regulatory submissions, and related records with accuracy and appropriate escalation.

Nice To Haves

Preferred experience with ISO 9001 and ISO 13485, audits, CAPA, risk management, document control, and quality-system implementation.
Knowledge of ISO/IEC 17025 is an advantage.
Experience in medical devices, life sciences, healthcare, diagnostics, laboratory products, or service-calibration environments is a plus.

Responsibilities

Serve as the SME for federal, state, and Canadian product regulations.
Translate changing requirements into clear actions for compliance and customer support.
Act as the regional point of contact for Quality Management and Regulatory Affairs for the Americas region.
Coordinate requests, escalations, and cross-functional support for Sales and Service.
Monitor and analyze federal, state, Canadian, and provincial requirements relevant to Eppendorf instruments, products, operations, waste, and gas.
Identify new or amended requirements, assess their applicability, and coordinate follow-up with Corporate Quality, Regulatory Affairs, and R&D.
Support and continuously improve the Commercial Quality Management System.
Prepare evidence, coordinate documentation, and support ISO audits for audits and inspections.
Respond to audit findings and follow corrective actions to closure.
Provide clear regulatory and quality documentation to customers and internal teams.
Support device registrations and submissions.
Deliver guidance, training, and practical support to strengthen quality and regulatory awareness.
Contribute to KPI reporting, process improvements, complaint handling, post-market surveillance, and service-calibration activities.