RA Specialist

Key Responsibilities

• Ensure submission and approval takes covering the new product registration, the registration amendment, and the renewal registration with high quality regulatory applications according to planned/committed timelines.

• Prioritize and develop strategies on product registrations including KGMP certifications for his/her respective product lines.

• Establishes and maintains relationships with local medical device industry groups and works with industry peers to respond accordingly to the Competent Authorities in matters of regulatory issues and to influence local policies.

• Ensure that his/her respective product lines comply with local regulations and quality system requirements.

• Serves as regulatory consultant to marketing team by providing input on regulatory-related issues in order to achieve the business plan.

• Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes and share the changes with internal stakeholders in a timely manner.

• Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.

• Participate in global/local projects to be compliant with global process and local regulations.

• Establish and maintain a good working relationship with regional/global RA peers to gain positive & timely support for document preparation.

• Build a constructive and trusted relationship with local health authorities through quality submission and active cooperation on any MFDS requests. This should include guidance on alternative solutions to country regulatory needs.

• Review marketing advertisements to ensure compliance to local regulations.

• Complete the mandatory Quality training subject to the defined timeline. And ensure compliance with internal Quality system and policy as well as local regulations to achieve stated objective.

Basic Requirements

• At least 3 years of RA experiences in medical devices.

• Good written and verbal communication skills in English.

• Bachelor’s Degree in Science/Engineering related majors preferred.

• Good problem-solving, interpersonal, and organizational skills.

• Good knowledge and understanding of relevant regulations to launch BSC product in Korea.

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