Sr. RA&PA Specialist

Job Description Summary

Sr. RA/PA Specialist will primarily be responsible for Regulatory Affairs activities, ensuring compliance with applicable regulations and managing submissions, approvals, and post-market requirements. The role also encompasses supporting Public Affairs initiatives, including market access/shaping, HTA processes, and HEOR, but with a strong emphasis on RA leadership. Key responsibilities include engaging with external stakeholders such as MFDS, MoH, HIRA/NECA, and NIDS to navigate regulatory frameworks and maintain product compliance. Candidates must have a solid background in RA processes and policies, with the ability to interpret and manage diverse regulations impacting the business. Experience in PA-related activities is an advantage, but expertise in RA is essential.

Job Description

Duties and Responsibilities

As a Sr. RA&PA Specialist at Becton, Dickinson and Company, you will have the opportunity to work on groundbreaking projects that build the future of healthcare. Your key responsibilities will include:

• Preparing submissions, reviewing responses, and documents intended for submission to MFDS to secure timely approvals and ensure compliance with regulatory requirements.
• Supporting the implementation of new product introductions by developing strategic regulatory plans.
• Reviewing product labeling and marketing materials for accuracy and regulatory compliance.
• Demonstrating a continuous pursuit of regulatory knowledge to gain expertise in product submissions and related regulatory/public affairs topics.
• Monitoring international laws and regulations and providing recommendations to ensure company compliance.
• Crafting well-written and effective responses to agency questions.
• Performing additional related duties and assignments as required.
• Monitoring change notifications and analyzing their impacts on product licenses, planning amendment activities, and applying corporate e-systems.
• Aligning market development needs for new products with business unit leaders to support business outcomes with agreed performance metrics.
• Managing market access cases for BD products, including reimbursement, new HTA applications, and pricing management based on knowledge of healthcare systems, policies, and payment systems.
• Supporting health economic analyses and evaluations to deliver efficient solutions to country health authorities using BD products.
• Performing submissions to Health Technology Assessment agencies evaluating BD products where appropriate.

• A Bachelor's degree or higher.
• A minimum of 6 years of experience in Regulatory Affairs within the medical device industry, including activities such as new submissions, change control, re-evaluation, and post-market compliance.
• Proven experience in acquiring approvals for Class III and Class IV medical devices.
• Experience in Public Affairs (e.g., reimbursement, market access, HEOR, HTA) is preferred but secondary to RA expertise.
• The ability to manage relationships with academic societies and key opinion leaders (KOLs).
• Strong attention to detail with a focus on accuracy and completeness.
• Proficient written and verbal communication skills in English and Korean.
• Excellent organizational and planning skills with a results-driven approach.
• Effective analytical, problem-solving, and time management abilities.