Regulatory Affairs Technical Specialist
- Represents Regulatory Affairs on Product Development Core Teams for Point-of-Care (POC) Diagnostics for in vitro diagnostics (IVD) products.
- Plans and prepares regulatory submissions for new product development to meet the requirements for US, EU (including 510(k)s, Pre-Submissions, Technical Files/STEDS) and collaborates with Siemens Regulatory affiliates worldwide to ensure country specific requirements are met.
- Supports the regulatory documentation for commercialized products including International registrations, Regulatory Assessments, and 510(k) Note-to-File justifications for product design changes etc.
- Performs review of promotional material and product labeling for regulatory compliance.
- Supports internal and external Quality audits/inspections.
- Interacts closely with multiple functions, including Manufacturing, R&D, Marketing, Logistics, Labeling etc.
- Minimum 5 years experience in Regulatory Affairs, preferably with a global manufacturer of IVD medical devices.
- Experience with managing and preparing complex Regulatory Submissions (510(k)s, PMAs, Pre-Subs, CE Mark Technical Dossiers, and other global regulatory submissions).
- Must have strong organizational and technical writing skills.
- Must have strong communication skills and work well with a team.
- Must have
experience working on multidisciplinary teams
in a fast-paced, dynamic environment.
- Must have experience reviewing product labeling, including advertising/promotional materials.
- Must be well versed in 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.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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