Software Regulatory Affairs Specialist - Population Health
Business Unit: Digital Services
Requisition Number: 240794
Primary Location: United States-Pennsylvania-Malvern
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 25%
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 Software Regulatory Affairs Specialist.
This is a role well suited to an ambitious professional, looking for the next step in their career. As a Software Regulatory Affairs Specialist you will be responsible for:
- Responsible to ensure regulatory compliance is met through the product development, implementation and delivery.
- Responsible to monitor and manage compliance to regulations and standards (QSR, ISO, MDR, CMDR and other applicable country regulations) throughout the development lifecycle.
- Participates to drive and implement Lean initiatives for quality relevant processes ensuring regulatory compliance is maintained.
- Participates and or supports Quality management in recommending processes changes or risks that ensure regulatory compliance is met within the strategic direction and or QMS compliance.
- Participates and or supports Quality processes
- Participates in audits and inspections by regulatory authorities and certification/accreditation bodies.
- Able to manage multiple projects, communicate updates, and meet milestones in a timely fashion.
- Displays a high level of critical thinking in bringing successful resolution to high impact, complex, and/or cross functional problems.
Required skills to have for the success of 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.
- 3 –5 years in the regulated related field and successful demonstration of key responsibilities and knowledge as stated above.
- Has knowledge and or experience with regulations and standards (i.e QSR, ISO, Canadian etc).
- Experience managing regulatory system elements within the QMS structure .
- Demonstrates a good grasp lean principles that can be applied through successful completion of assignments. Value stream mapping experience a plus.
- Strong interpersonal, communication and organizational skills required.
- Must be able to set priorities as well as adapt to changing priorities.