Yunus Gulmez
About Yunus Gulmez
Yunus Gulmez is a Regulatory Affairs Specialist at Boston Scientific with extensive experience in regulatory and quality assurance roles across the medical device and biotech industries.
Title and Current Position
Yunus Gulmez is a Regulatory Affairs Specialist at Boston Scientific. He has been with the company since 2016, working in Marlborough, Massachusetts, United States.
Previous Experience at Medtronic
Yunus worked as an International Regulatory Affairs Specialist at Medtronic in 2016. He was based in Minneapolis, Minnesota, United States, and served the company for 2 months.
Role at Sanofi Genzyme
From 2014 to 2016, Yunus was employed at Sanofi Genzyme as a Quality Engineer. He worked out of Cambridge, Massachusetts, United States for a period of 2 years.
Work at Respiratory Motion, Inc.
From 2013 to 2014, Yunus served as a Regulatory Affairs and Quality Assistant for Respiratory Motion, Inc. during his one-year tenure in Watertown, Massachusetts, United States.
Academic Background and Pharmacy Studies
Yunus has a diverse educational background in Pharmacy. He achieved his Masters of Science in Pharmacy in 2014 and studied at Regis College from 2013 to 2014. He also attended Università Degli Studi Di Sassari for a year from 2008 to 2009 and completed his Bachelor's at Hacettepe University from 2005 to 2011.
Research Experience
Yunus gained research experience as a Researcher at Università Degli Studi Roma Tre in 2011. He worked in Citta Metropolitana Di Roma Capitale, Latium, Italy.
Regulatory Affairs Expertise
Yunus specializes in preparing international documentation to support product registration globally, focusing primarily on medical devices and biotech products. He is well-versed in international regulations like ISO 13485, various CFR Parts, MDD requirements, and ICQ Guidelines. His work also includes supporting the submittal of US 510(k), PMA, and CE certifications.
Quality Assurance Process Development
Yunus has developed Quality Assurance and Regulatory Affairs processes that ensure compliance with both domestic and global regulatory requirements. His experience includes extensive work with raw materials for labeling and supplier documents.
Multilingual Communication Skills
Yunus is fluent in English, Italian, and Turkish, and conversational in Spanish. This multilingual capability enhances his communication effectiveness in various regulatory contexts.