Sr RA Specialist

• 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. 

• →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

• 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

• 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

• 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

In specific locations, the pay range may vary from the range posted.