Natalie Levin

Background

About Natalie Levin

Regulatory & Compliance Professional with 20 years of experience in medical device & IVDD regulatory affairs for clinical chemistry and transfusion medicine businesses in international markets. Experienced in industry representation through MedTech sub-committee involvement and ongoing regulatory intelligence. Ownership of global QMS compliance program with focus on ISO13485:2016 / MDSAP certification and QMS maturity. Internal and external audit management and coordination. Past experience with post-market product life-cycle risk management planning and global recall execution and AE reporting. Interested in global regulatory frameworks/submission strategy, compliance/continuous improvement programs, CAPA optimization, QMS harmonization tactics and sharing of best practices. Established global EHS framework, objectives and sustainability program according to national and global compliance standards. Leadership of Technical Publications team tasked with labelling asset management and modernization of all user documentation for +700 products. Specialties: Canadian medical device/IVDD regulatory compliance; pre-market RA strategy and post-market product lifecycle management responsibility; presentation preparation and delivery; relationship strategist; change management advocate. Current key therapeutic areas of expertise: in vitro diagnostic devices (clinical chemistry & immunohematology). Current Geographic Experience: Global (with past regional focus in Canada & Latin America) Previous key therapeutic areas of expertise: orthopaedics, cardiology, aesthetic medicine, general surgery and laparoscopic intervention.