Regulatory Affairs Technical Specialist
Now’s our time to inspire the future of healthcare together.
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
Join our team now at Siemens Healthineers as a Regulatory Affairs Technical Specialist.
This is role is well-suited to an ambitious
professional looking for the next step in your career. As a Regulatory Affairs Technical Specialist you will be responsible for:
- Representing Regulatory Affairs on Product Development Core Teams for Point-of-Care (POC) Diagnostics for in vitro diagnostics (IVD) products.
- Planning and preparing regulatory submissions for new product development to meet the requirements for US, EU (including 510(k)s, Pre-Submissions, Technical Files/STEDS) and collaborating with Siemens Regulatory affiliates worldwide and OEMs to ensure country specific requirements are met.
- Supporting the regulatory documentation for commercialized products including International registrations, Regulatory Assessments, and 510(k) Note-to-File justifications for product design changes etc.
- Performing review of promotional material and product labeling for regulatory compliance.
- Supporting internal and external Quality audits/inspections.
- Interacting closely with multiple functions, including Manufacturing, R&D, Marketing, Logistics, Labeling etc.
Experience and requirements for success in this role:
- BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas.
- 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.
- Experience in Rapid Testing Preferred
Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full vaccination for COVID-19 for our U.S. employees, contractors, and business partners, where local conditions allow, who:
1) Are customer-facing (e.g., those required to visit a customer/business partner site or interact in-person with customers at any conference or meeting) OR
2) Come on-site, whether regularly or occasionally, at any Siemens Healthineers location.
(Note: Accommodations may be requested for certain medical or religious reasons)
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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