Global Quality & Regulatory Affairs Specialist

Eppendorf; Enfield (CT); Hybrid; USD 70,000 - 75,000; Full time

Job summary

Eppendorf seeks a Quality & Regulatory Affairs Specialist to act as the SME for federal, state, and Canadian product regulations. You will translate changing requirements into clear actions that help our teams stay compliant and support customers.

You will coordinate requests and cross-functional support for Sales and Service across the Americas, monitor regulatory requirements, and assist with registrations and submissions.

Qualifications

• Bachelor’s degree required; experience in regulatory analysis and interpretation.
• Translate federal, state, Canadian, or provincial requirements into actionable guidance for stakeholders.
• Experience with ISO 9001 and ISO 13485, audits, CAPA, risk management, and document control is preferred.

Responsibilities

• Serve as the SME for federal, state, Canadian product regulations across the Americas region.
• Coordinate requests, escalations, and cross-functional support for Sales and Service.
• Monitor and analyze regulatory requirements using databases and government sources.
• Identify new or amended requirements and coordinate follow-up with Quality, Regulatory Affairs, and R&D.
• Support and improve the Commercial Quality Management System, including document control and CAPA.
• Prepare documentation for audits and inspections and support ISO audits; travel may be required.
• Provide regulatory and quality documentation to customers and internal teams; assist with registrations and submissions.

Skills

Regulatory analysis

Cross-functional coordination

Regulatory guidance

Quality documentation

Process improvements

Education

Bachelor’s Degree

Tools

Regulatory databases

Job description

How you can make an impact

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.

What sets you apart

• Preferred Background
  
  • Bachelor’s Degree
  • Background in regulatory analysis and interpretation, and you can turn complex federal, state, Canadian, or provincial requirements into clear, actionable guidance for business and technical stakeholders.
  • 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 environmentsis a plus
  • You can coordinate complaint handling, adverse-event reporting, field-safety corrective actions, post-market surveillance, product registrations, regulatory submissions, and related records with accuracy and appropriate escalation.
  
  
  

What we offer

• We see what you achieve. You will receive an annual salary of $70,000–$75,000 and a quarterly bonus structure.

• Purpose and impact. You help customers successfully run bioprocesses that underpin therapies and innovations, directly contributing to improving human living conditions.
• Comprehensive benefits. A competitive total rewards package, including health, financial, and education benefits, supports you in different stages of life.
• Collaborative environment. Close collaboration with sales, service, and global product teams in a culture that values innovation and customer focus.