MAIN RESPONSIBILITIES :
- Manage activities associated with pre-market approval and ensure regulatory compliance for current and future pipeline.
- Be partner with counterpart local and HQ to support local planning in accordance with national regulatory requirements aligned with global plan.
- Manages project progress and self-assessment activities under the compliance framework.
- Monitor and assessment changes in regulatory environment trend.
- Work towards achieving RA goals aligned with company vision, objectives as well as divisional mission and strategies.
- Prepare submission for each business unit and correspondence with Global RA Affiliates.
- Be in charge of the potential re-evaluation/re-assessment and renewals/tracking devices/post market surveillance.
- Responsible for product change notification/control process. Assess change notice and report local requirements.
- Cross-functional collaboration with Sales/marketing, Customer service, QA, Finance, etc
▣ 자격요건
MINIMUM SKILLS REQUIRED :
- Good computer skills with proficiency with Microsoft applications and Adobe Professional.
- Good verbal and written communication skills, presentation skills
- Good interpersonal skills, the ability to build and maintain relationships with key stakeholders
- Good decision-making, problem solving and project management skills
- Ability to work in an international environment
- Ability to prioritize regulatory activities according to organization goals
- Excellent spoken and written of English and local language
- Enjoys interacting and participating in a team environment
- Can work autonomously
- Self-motivated and positive with “can do” attitude
- Willingness and ability to learn complex technical information
- Detail, results and deadline oriented
KNOWLEDGE / EDUCATION REQUIRED :
- Strong knowledge in of regulatory affairs in medical device, healthcare business and/or environment, etc.
- Major in Life Science, Medical Engineering, Medicine, Pharmacy, Nursing, etc. are preferred.
- Experience in submission and approval of Class IV devices
- Experience in product registration with clinical data review
EXPERIENCE REQUIRED :
- Bachelor Degree : 6 to 10 years of relevant experience (general electronic science/Biology/Biomed degree)
- Master Degree : 5 to 7 years of relevant experience
- Experience gained in multinational medical device companies will be beneficial
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ㆍ서류전형 > 1차면접 > 2차면접 > 임원면접 > 최종합격
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