Quality & Regulatory Affairs Specialist

Improving human living conditions – that is our shared purpose at Eppendorf. With our high-quality, precise premium life science products – from pipette tips, dispensers and centrifuges to bioreactors and ultra-low temperature freezers – we help scientists around the world conduct research in the lab faster, more accurately and more efficiently.

I listen to truly understand.
I lead the way, even when the path ahead is not yet clear.
I stand by what I say.
I make progress visible and share what I learn.

If this resonates with you, you are exactly who we are looking for.
You will work with people who combine different perspectives and make new things possible. You contribute your ideas, ask questions, challenge the status quo – and you will find an environment that empowers you and helps you grow. Because we believe in people who want to shape the future. People like you.

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 environments is 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.

What matters to us

At Eppendorf, we believe that science thrives on curiosity – and on many different perspectives.

Our Eppendorf team is as diverse as the questions asked across the life sciences. Different backgrounds and ways of thinking help us develop better solutions for research.

Come as you are, bring what makes you unique – and help us shape what diversity can make possible in science.

Please note that we can only consider applications submitted via our online application system.

We look forward to getting to know you.

If you have any further questions, please contact:

Whitney M Furey (contact person)

furey.w@eppendorf.com

Eppendorf. Collaborate on new ideas.