Kelly Kucharczyk
Happiest when partnering with MedTech Companies to develop successful market access strategies
- Role
- Associate Director, Global Medical Writing and North American Raqa Services at NAMSA
- Location
- Lawton, MI, US
- LinkedIn followers
- 500 followers
About Kelly Kucharczyk
I am a passionate and driven RAQA leader with 14 years of experience in the Medical Device industry. I have a track record of recruiting and developing highly talented RA professionals focused on creative solutions, turning RA into a sought-after function. I love tackling new challenges, learning in a fast-paced and dynamic environment, and developing strategies for complex regulatory situations, all while building relationships and delivering business results. My regulatory expertise is with non-active implants and delivery systems, SaMD and SiMD, RF ablation, cutting technologies, endoscopy, HCT/Ps, and biologics. Specialties: regulatory affairs, 510(k) submission & process, clinical evaluation reports, MEDDEV 2.7/1, quality system documentation, mergers & acquisitions, due-diligence activities, EU MDR, FDA inspections, Notified Body Audits, marketing collateral, on-label compliance, NC & CAPA, international submissions, international & domestic product registration, internal audits, FDA & ISO requirements, MDR and MDV reporting, product field actions
Experience
Associate Director, Global Medical Writing and North American Raqa Services
Sep 2021 — Present · US
Education
Western Michigan University
BS, Chemical Engineering
2006 — 2010
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