Nina Vollmer
Senior Regulatory Affairs Specialist @ Medtronic | PhD in Materials Science
- Role
- Senior Regulatory Affairs Specialist at Medtronic
- Location
- Englewood, CO, US
- LinkedIn followers
- 500 followers
About Nina Vollmer
At Medtronic, my role as a Senior Regulatory Affairs Specialist involves developing strategic responses to FDA communications and ensuring that our Class I, II, and medical devices meet stringent regulatory standards. In collaboration with cross-functional teams, we\'ve effectively navigated challenges, such as CAPA and FDA 483 resolutions, enhancing regulatory compliance and product quality.Previously, as a Senior Scientist in R&D at AlloSource®, I spearheaded technical projects, translating complex biocompatibility and cytotoxicity data into actionable insights for product development. My expertise in biopharmaceuticals is underpinned by a robust analytical skill set, garnered through significant research in materials science, which continues to inform my approach to innovation in medical device regulation.
Experience
Senior Regulatory Affairs Specialist
May 2025 — Present · Mounds View, MN, US
Education
Colorado School of Mines
Doctor of Philosophy (PhD), Materials Science
2010 — 2014
Colorado School of Mines
Master of Science (MS), Materials Science
2007 — 2010
Colorado School of Mines
Bachelor of Science (BS), Metallurgical and Materials Engineering
2002 — 2006
Skills
- Research
- Science
- Combustion Synthesis
- Calcium Phosphate
- Microscopy
- Cell Culture
- Extracellular Matrix
- Data Analysis
- Bone
- Tissue Engineering
- Matlab
- Materials Science
- Biomedical Engineering
- Engineering
- Microsoft Office
- Biomaterials
- Combustion Synthesis
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