Sr RA Specialist

JOB DESCRIPTION:

ABOUT ABBOTT:
At Abbott, we’re dedicated to helping people live more fully, in everything we do. We’re creating the future of healthcare through life-changing technologies and products that make you healthier and stronger, quickly identify when you have a medical need, and treat conditions to help you get back to doing what you love.
With global headquarters in Chicago, USA, we serve people in more than 160 countries with leading medical devices, diagnostics, nutrition products and branded generic medicines. Our 115,000 colleagues are helping millions of people to live better and healthier, every day around the world. In South Korea, we’ve been helping people live fully for more than 30 years.

Location : 대치동 & 역삼동

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

The base pay for this position is

N/A

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

     

JOB FAMILY:

Regulatory Operations

DIVISION:

MD Medical Devices

LOCATION:

Korea > Seoul : SamTan Building, 421 Youngdong-daero, Gangnam-gu

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable