LiJuan He -

APAC RA Director @ Johnson & Johnson MedTech

About

Passionate, goal-oriented Research & Development and Regulatory Affairs Professional with proven domestic and global experience in highly regulated working environments. Documented success in developing project initiatives, directing project plans and achieving performance targets. Known for strengths in people management, talent development, strategic thinking, decisive decision making and analytics, persuasive communication, and leading cross-functional and global teams to achieve results. Ability to work globally with Franchise & Regional senior leaders on operational progress & performance.

Country

United States

City

Greater Boston

Industry

Medical Device

Skill

Change Management, Leadership, Talent Management, Directing Talent, Talent Developer, Cross-cultural Communication Skills, Cross Functional Relationship Building, Bilingual Communications, Team Leadership, innovation, Influence Others, Global regulatory, Due Diligence, Project Management, New Business Development, International Project Management, Process Control, Thin Film Coating, Process Improvement, FDA

Experience

APAC RA Director

Johnson & Johnson MedTech

2023-11 - Present · 2 yrs 11 mos

Singapore

Special Projects Regional Lead APAC, Regulatory Affairs

Johnson & Johnson

2016-4 - 2023-11 · 7 yrs 8 mos

Raynham, MA

Associate Director, Regulatory Affairs- Business Process Excellence Medical Device

Johnson & Johnson

2015-8 - 2016-4 · 9 mos

Raynham, MA

Lead effort to develop a draft single STeD plus format for global registration effectiveness

Regulatory Project Manager - Asia Pacific

Johnson & Johnson

2013-1 - 2015-7 · 2 yrs 7 mos

325 Paramount Dr. Raynham, MA 02767

Ensure successful approval and renewals of DePuy Synthes product registrations in China. Develop strategies and interface directly with Chinese government officials at the Chinese National Testing Centers and Chinese Center for Medical Device Evaluation to facilitate approvals of DePuy Synthese products in China. Participate in new business development effort.

Sr. Material Engineer, Staff Engineer & Certified Six Sigma Black Belt

Johnson & Johnson

2005-12 - 2013-1 · 7 yrs 2 mos

325 Paramount Dr. Raynham, MA 02767

Neuro medical device product development to treat hydrocephalus and neurovascular diseases

Sr. R & D Engineer

Boston Scientific

2003-12 - 2005-12 · 2 yrs 1 mo

Natick, MA

Drug eluting stent coating formulation, coating process development and technology transfer.

Material Engineer, Sr. R & D Engineer & Certified Six Sigma Black Belt

Avery Dennison

1997-1 - 2003-12 · 7 yrs

Indiana Area, Ohio Area

Automotive dry paint film coating characterization & new formulation development. Technology transfer to Asia Pacific Region. New product development for reflective sheeting, Label & Adhesive products etc. Coating characterization and process development.