Regulatory Technical Specialist 2

Regulatory Technical Specialist II - IVDR 
Location: Norwood, MA 02062
Duration: 12 Months

 Key Responsibilities: 
• Represents Regulatory Affairs in Project Team for implementing new EU In Vitro Diagnostic Medical Device Regulations (IVDR) within the Point of Care Business Line for Siemens Healthineers. 
 • Responsible for executing a gap analysis of commercialized IVD products, reviewing reports, and providing guidance to Project Team for updating technical documentation, labeling, etc. for meeting the IVDR requirements. 
 • Responsible for preparing summary technical documentation (STED) according to EU IVDR for Notified Body review. 
 • Interacts closely with Regulatory IVDR project team lead and other functions, including Program Management, R&D, Clinical Affairs, Labeling, Risk Management, etc. 
 • May interact directly with Notified Body during the preparation and review of submissions. 
 Preferred Skills: 
 - 2 – 5 years experience in Regulatory Affairs, preferably with a global manufacturer of medical devices. 
 - Experience with preparing 510(k)s, Pre-Submissions, EU Essential Requirements Checklists/Technical Files and other regulatory submissions. 
 - Strong attention to detail with organizational and technical writing skills. 
 - Strong knowledge of US FDA, EU IVD and/or MD regulations 
 - Experience working on multidisciplinary teams in a fast-paced, dynamic environment. 
 - Strong written and verbal communication skills. 
 - Well versed QSR Design Control requirements and in educating project teams on these requirements. 
 - BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.

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