Regulatory affairs project management
1. Manage Medical device regulatory affairs projects agreed with head of division and management
o Provide short/mid term RA project plans to align with company strategy
o Ensure to complete regulatory affairs projects timely manner according to milestone as agreed as company strategic initiative.
o Ensure RA communication flow is in place and effective
2. Ensure product life cycle management in Korea in place and ensure post approval change controls are done as required.
o Provide regular assessment of post approval change control plan to mitigate the risk and prioritize the RA projects.
o Ensure regulatory risk management is done in timely manner
3. Establish and maintain strong business relationship with CoE GRA and internal stakeholders, as well as external stakeholders.
4. Collaborate with internal stakeholders to pursue cross functional alignment regarding company processes and policy for regulatory projects.
5. Align with Head of division on resource planning and RA budget regarding regulatory projects.
6. Provide regular monitoring and business impact analysis of regulatory environment changes and share them with wider group as required to ensure alignment.
People management
1. Support Head of division to build a strong RA team of professionals with high level of engagement, optimal performance and in-depth job competency.
2. Provide role modeling and proper daily coaching to subordinates to ensure their communication and behaviors are at optimal level as required by company.
3. Ensure active engagement in business initiatives (e.g. Powerhouse Strategy) and provide professional input to company strategy as required.
4. Identify and develop RA talents and succession plan.
5. Understand and implement company policy and guideline as required as people leader.
6. Ensure RA process and procedures are written and project information are archived.
경력 및 자격요건
Education
• 4 years university degree in life science or medical engineering. Higher degree with medical device related area preferred.
Experience
• Minimum 10 years relevant experience in healthcare or medical device industry.
• Multinational company experience preferred
• Experience of leading people or sub team preferred.
Specific knowledge /skills
• Effective and clear communication and sound interpersonal skills
• Strategic, willing to achieve and result oriented
• Ability for problem solving and decision making
• Extensive knowledge of relevant international and Korean regulations
• Good command of spoken and written English
• Strong network with external stakeholders and competent authorities
• Ability to work under competing priorities and to work cross functionally.
기타
- 원서 마감후 1차(서류) 합격자에 한하여 개별연락
- 이력서에 연락처, 희망연봉 게재
- 해외여행에 결격 사유가 없는 자
담당업무
입사지원
돌아가기
02-6281-5015
yhw@nterway.com
