전형절차 ㆍ서류전형 > 1차면접 > 2차면접 > 임원면접 > 최종합격 ㆍ면접일정은 추후 통보됩니다. |
Medical Device Sr.RA
포지션 및 자격요건 |
포지션 |
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 |
전형절차 ㆍ서류전형 > 1차면접 > 2차면접 > 임원면접 > 최종합격 ㆍ면접일정은 추후 통보됩니다. |
유의사항 ㆍ허위사실이 발견될 경우 채용이 취소될 수 있습니다. |