RA specialist

 

$ads={1}

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.

CORE JOB RESPONSIBILITIES :

Responsible for activities associated with pre-market approval and ensure regulatory compliance for current and future pipeline. Collaborates with counterpart local and HQ to support local planning in accordance with national regulatory requirements aligned with global plan. Monitors project progress and self-assessment activities under the compliance framework. Monitors 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. Handles the potential re-evaluation/re-assessment and renewals/tracking devices/post market surveillance. Responsible for product change notification/control process. Assess change notice and communicate local requirements with global RA. 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 : 3 to 5 years of relevant experience (general electronic science/Biology/Biomed degree)
• Master Degree : 2 to 4 years of relevant experience
• Experience gained in multinational medical device companies will be beneficial

$ads={2}

 

.