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JOB PURPOSE AND SCOPE :
ㆍBe responsible for the preparation and submission of product registration and get approval from the local health authorities ㆍMaintain Product license aligned with the current Abbott in-house specification and MFDS requirements - ㆍMonitor and assess the regulatory changes and emerging issues to evaluate the impact in business.
CORE JOB RESPONSIBILITIES : - ㆍManage activities associated with pre-market approval and ensure regulatory compliance for current and future pipeline.
- ㆍBe partner with counterpart local and HQ to support local planning in accordance with national regulatory requirements aligned with global plan.
- ㆍManages project progress and self-assessment activities under the compliance framework.
- ㆍMonitor and assessment changes in regulatory environment trend.
- ㆍWork towards achieving RA goals aligned with company vision, objectives as well as divisional mission and strategies.
- ㆍPrepare submission for each business unit and correspondence with Global RA Affiliates.
- ㆍBe in charge of the potential re-evaluation/re-assessment and renewals/tracking devices/post market surveillance.
- ㆍResponsible for product change notification/control process. Assess change notice and report local requirements.
- ㆍCross-functional collaboration with Sales/marketing, Customer service, QA, Finance, etc
MINIMUM SKILLS REQUIRED : - ㆍGood computer skills with proficiency with Microsoft applications and Adobe Professional.
- ㆍGood verbal and written communication skills, presentation skills
- ㆍGood interpersonal skills, the ability to build and maintain relationships with key stakeholders
- ㆍGood decision-making , problem solving and project management skills.
- ㆍAbility to work in an international environment
- ㆍAbility to prioritize regulatory activities according to organization goals
- ㆍExcellent spoken and written of English and local language
- ㆍEnjoys interacting and participating in a team environment
- ㆍCan work autonomously
- ㆍSelf-motivated and positive with "can do" attitude.
- ㆍWillingness and ability to learn complex technical information.
- ㆍDetail, results and deadline oriented
KNOWLEDGE/ EDUCATION REQUIRED :
- ㆍStrong knowledge in of regulatory affairs in medical device, healthcare business and/or environment, etc.
- ㆍMajor in Life Science, Medical Engineering, Medicine, Pharmacy, Nursing, etc. are preferred.
- ㆍExperience in submission and approval of Class IV devices.
- ㆍExperience in product registration with clinical data review
EXPERIENCE REQUIRED :
- ㆍBachelor Degree : 6 to 10 years of relevant experience (general electronic science/Biology/Biomed degree)
- ㆍMaster Degree : 5 to 7 years of relevant experience
- ㆍExperience gained in multinational medical device companies will be beneficial
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