Norwood, United States
2 months ago
Regulatory Technical Specialist II - IVDR Key Responsibilities:
- Supports 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 support responses to Notified Body during the preparation and review of submissions.
- May support additional regulatory registrations and functions outside the scope of IVDR
- 2 - 5 years experience in Regulatory Affairs, preferably with a global manufacturer of medical devices.
- Experience with preparing 510(k)s, PreSubmissions, 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
- Project Management Experience
- BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.