A BOUT ABBOTT :

　　Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

　　JOB PURPOSE AND SCOPE :

　　Be responsible for the preparation and submission of product registration and get approval from the local health authorities

　　Maintain Product license aligned with the current Abbott in-house specification and MFDS requirements

　　Monitor and assess the regulatory changes and emerging issues to evaluate the impact in business.

　　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

　　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

　　An Equal Opportunity Employer

　　Abbot welcomes and encourages diversity in our workforce.

　　We provide reasonable accommodation to qualified individuals with disabilities.

　　To request accommodation, please call 224-667-4913 or email [email protected]