The Senior, Regulatory Affairs Specialist is responsible for acting as the regulatory representative on product development teams aiming to achieve and maintain regulatory compliance for NanoString’s products, with a particular focus on instrument/software development and manufacturing.

Essential Functions: 

• Maintain Regulatory Affairs documents, policies, plans and procedures to support compliance with regulatory requirements
• Review labeling/promotional/advertising materials, and other documents to ensure regulatory compliance
• Represent and/or lead Regulatory affairs in project team meetings throughout the lifecycle of large-scale projects
• Assist in the interpretation and submission of domestic and international regulatory registrations, testing and certifications
• Assist regulatory initiatives for compliance and risk management
• Interpret Regulatory Affairs policies and guidance and correctly apply them as regulatory activities
• Manage for the successful execution of regulatory plans
• Participate in internal and external Quality and Regulatory audits
• Maintain current knowledge of relevant regulations and trends, including proposed and final rules
• Use excellent time management, verbal and written communications

Requirements:

• BA/BS degree is required
• Previous in vitro diagnostic (IVD) nucleic acid experience, a plus
• 2-5 years of (hands on) experience in Regulatory Affairs
• Working knowledge of FDA QSR, ISO 13485 and ISO 9001 regulations
• Experience in a Molecular Biology research environment, a plus
• Excellent interpersonal skills with the ability to influence others in a positive and effective manner
• Strong organizational skills and the ability to support multiple projects
• Proven ability to work on product development teams
• Intellectual curiosity and an ability to digest complex technical data

Preferred Qualifications:

• Preferred education/experience includes bioengineering, biological, physical, clinical and regulatory sciences. Advanced degrees (MS, MBA, PhD., etc.) a plus
• Strong intellectual capacity and curiosity desired
• Previous in vitro diagnostic (IVD) nucleic acid experience highly preferred
• Certifications: RAC, CQA, CQM preferred