Senior Medical Device Regulatory Affairs Specialist

Stratasys is a world leader in 3D printing!

Stratasys is leading the global shift to additive manufacturing with innovative 3D printing solutions for industries such as aerospace, automotive, consumer products and healthcare. Through smart and connected 3D printers, polymer materials, a software ecosystem, and parts on demand, Stratasys solutions deliver competitive advantages at every stage in the product value chain. The world’s leading organizations turn to Stratasys to transform product design, bring agility to manufacturing and supply chains, and improve patient care.

Overview

The Senior RA specialistwill be responsible for leading global market expansion and new product introductions for Class I, Class II (US) and Class IIa (EU) medical devices. Responsibilities include planning and executing regulatory submissions for the US, EU, and other international markets, creating and maintaining technical files, managing complaints, overseeing change activities, and ensuring post market compliance. The role collaborates with cross functional teams – including QA, R&D, Clinical, Manufacturing, Operations, Marketing, and Commercial – to ensure compliant efficient, and timely market access throughout the product lifecycle, including sustained compliance.

Responsibilities

Market Expansion & Global Regulatory Registrations

• Prepare and maintain global regulatory submissions (e.g., India, Australia, Singapore, Mexico) and author full submission packages. (e.g., EU MDR Annex II/III TD, US 510(k), ANVISA, SFDA, NMPA).
• Monitor regulatory changes and ensure sustained compliance across all markets, including labeling, UDI, and post-market updates.
• Conduct jurisdiction -specific impact assessment for product changes and manage global propagation of design, labeling and UDI updates.
• Collaborate with R&D, Operations, Marketing, and product teams throughout new product development and commercialization to ensure regulatory alignment
• Review technical documentation and ensure compliance across the full product lifecycle
• Serve as the QA/RA point of contact for cross-functional programs and regulatory-related initiatives.
• Maintain existing registrations, manage renewals and variations, and oversee global portfolio compliance.
• Develop and execute global regulatory strategies for new market entry (US 510(k), EU MDR, Canada MDL, LATAM, APAC, MEA), including interpret country-specific requirements, identification of testing and labeling needs, and creation of submission roadmaps.
• Lead pre-submission meetings and manage interactions with health authorities and notified bodies.
• Ensure compliance with ISO 13485, 21 CFR 820, EU MDR, and applicable country regulations.
  
  

• Develop, implement and maintain processes to ensure compliance with applicable regulatory standards and requirements
• Maintain documentation and quality records in compliance with ISO 13485, QMSR,
• and internal QMS (e.g., change management, technical file updates)
• Support internal audits, management reviews, and quality improvement initiatives
• Participate in risk management activities and lead or support CAPA investigations, nonconformances and root cause analysis
• Serve as the company’s Complaint Designated Unit (CDU), managing the full lifecycle of medical devices complaints, including trend analysis, investigations, and reporting to authorities.
• Participate in external audits and inspection readiness activities
• Conduct regulatory gap assessments and execute remediation plans (CER updates, PMS/PMCF plans, ISO 14971 risk management).
• Drive closure of regulatory-related CAPAs and support audit and inspection readiness.
• Manage post-market surveillance deliverables (e.g., PSUR, vigilance reporting) and ensure timely corrective actions.
  
  

• Follow all company policies and procedures (safety, compliance etc)
• Attend all required company training
• Demonstrate commitments to Stratasys Behaviors by leading, acting, and modeling these values.
  
  

• 7+ years of experience in QA/RA roles within the medical device, dental, or healthcare industry with global submissions experience
• Experience with ISO 13485, EU MDR, and FDA 21 CFR Part 820 requirements
• Experience with global submissions and registrations of medical devices
• Experience with additive manufacturing and Class I/II medical devices
• Familiarity with eQMS tools and regulatory databases (e.g., EUDAMED, FDA portals)
• Strong writing, documentation, and analytical skills
• Demonstrated expertise in negotiating and maintaining relationships with authorized representatives, consultancy providers, including contract signing and service agreement management.
• Experience with project management includint managing multiple projects
  
  

• Company Overview - https://www.stratasys.com/en/about-us/history/
• Our Culture and Values - https://www.stratasys.com/en/about-us/culture/
• Our Sustainability “3D Printing a Better Tomorrow” - https://www.stratasys.com/en/about-us/sustainability/
• Our Locations - https://www.stratasys.com/en/contact-us/office-locations/
• Check out our Video - https://www.youtube.com/watch?v=6wmDfmt2bNI