Real Staffing
Senior Regulatory Affairs Specialist OUS
Real Staffing, Thousand Oaks, California, United States, 91362
Overview
We have an amazing opportunity with our growing client in the class II/III implant space. Our client is global and looking to bring in a tenured Senior Regulatory Affairs Specialist who will be shaping and driving global regulatory strategy. Here you will be responsible for authoring regulatory submissions, providing critical input on cross-functional projects, and leading major product registrations for global markets. Responsibilities
Author regulatory submissions for global markets Provide critical input on cross-functional projects related to regulatory strategy Lead major product registrations for global markets Qualifications
4+ years of global regulatory experience in medical devices Previous experience with implant devices Class II or III devices Experience with global medical device regulations (EU MDR, MDSAP, NMPA, etc.) Previous experience leading LATAM, APAC and MENA registrations Strong understanding of product development and design control Prior involvement with clinical studies and product lifecycle planning Ability to come on-site Benefits and Equal Opportunity
EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change. To find out more about Real Staffing, please visit www.realstaffing.com #J-18808-Ljbffr
We have an amazing opportunity with our growing client in the class II/III implant space. Our client is global and looking to bring in a tenured Senior Regulatory Affairs Specialist who will be shaping and driving global regulatory strategy. Here you will be responsible for authoring regulatory submissions, providing critical input on cross-functional projects, and leading major product registrations for global markets. Responsibilities
Author regulatory submissions for global markets Provide critical input on cross-functional projects related to regulatory strategy Lead major product registrations for global markets Qualifications
4+ years of global regulatory experience in medical devices Previous experience with implant devices Class II or III devices Experience with global medical device regulations (EU MDR, MDSAP, NMPA, etc.) Previous experience leading LATAM, APAC and MENA registrations Strong understanding of product development and design control Prior involvement with clinical studies and product lifecycle planning Ability to come on-site Benefits and Equal Opportunity
EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change. To find out more about Real Staffing, please visit www.realstaffing.com #J-18808-Ljbffr