Head of RA - Korea
On-siteSeoul, Seoul, South Korea
Job Summary
Develop regulatory strategy and direction for product launches, premarket submissions, and postmarket compliance while working closely with healthcare regulatory bodies in Korea. Provide specialized expertise as a best practice resource, contribute to strategy and policy development, and lead small projects with moderate risks. Communicate complex messages to build consensus and influence approaches across the functional area. Use technical experience and data analysis to support recommendations and solve moderately complex tasks impacting the function. Requires 15+ years in Quality & Regulatory Affairs, people leadership experience, and strong communication skills.
Required Qualifications
- Min 15+ years of experience in the Quality & Regulatory Affairs
- preferred medical device industry
- Knowledge level is comparable to a Master's degree from an accredited university or college
- high school diploma with relevant experience
- Demonstrated experience in people leadership, including performance management, coaching, mentoring, and talent development
Desired Qualifications
- 15년 이상의 경력을 보유하고 있으며, 팀 운영 및 구성원 관리 경험을 포함한 피플 매니징 경험을 갖춘 분을 선호합니다
- Strong oral and written communication skills
- Strong interpersonal and leadership skills
- Demonstrated ability to analyze and resolve problems
- Demonstrated ability to lead programs / projects
- Ability to document, plan, market, and execute programs
- Established project management skills
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