Sr. Regulatory Affairs Specialist

[An Exciting Opportunity]

Boston Scientific Korea is seeking a highly motivated and responsible Sr. Regulatory Affairs Specialist. Our global mission is to transform lives through innovative medical solutions that improve the health of patients. The vision of Boston Scientific RA is to be a strategic business partner dedicated to accelerating regulatory approvals, through high performance and innovative solutions, enabling exceptional patient care. If you want to develop your RA competency and contribute to improve the quality of patient lives, please join us.

[Position Summary]

Sr. Regulatory Affairs Specialist is responsible for leading regulatory submission strategies, ensuring compliance with applicable regulations, and serving as a key liaison between local authorities, global RA teams, and internal stakeholders. This role requires in-depth regulatory knowledge, project leadership skills, and the ability to guide junior team members.

[Key Responsibilities]

1. Regulatory Strategy & Submission Management

• Develop and prioritize strategies for regulatory approvals, including new product registrations, license renewal, license re-evaluation, and KGMP certifications (excl. KGMP recertification), for assigned product lines
• Ensure timely submissions and approvals through high-quality regulatory applications aligned with planned or committed timelines
• Collaborate with global and regional RA peers to align strategies and provide timely regulatory support
• Serve as a regulatory consultant to the marketing team, offering input to support business objectives

2. Compliance Across Product Lifecycle

• Ensure regulatory compliance throughout the product lifecycle, including labeling, advertising/promotional material review, and product change management
• Complete all mandatory quality training within designated timelines and ensure compliance with internal quality systems, policies, and applicable local regulations
• Support internal and external audits related to BSK-owned products

3. Regulatory Intelligence & Policy Engagement

• Monitor emerging regulatory trends and assess their potential impact on organizational processes; proactively share relevant updates with internal stakeholders
• Represent the company in local medical device industry associations, collaborating with industry peers to respond to regulatory authorities and contribute to policy development
• Participate in global and local projects to ensure alignment with global processes and adherence to local regulatory requirements

4. Authority & Stakeholder Relationship Management

• Build constructive and trusted relationships with local health authorities through high quality submissions, timely responses to MFDS requests, and well-supported scientific justification, including alternative solutions when appropriate
• Maintain active engagement with industry associations to strengthen BSK’s influence in shaping local regulatory policy

[Required Qualifications]

• Bachelor’s degree in biomedical engineering, life sciences, or a related field
• 7-9 years of hands-on experience in Regulatory Affairs within the medical device industry
• Strong knowledge and understanding of medical device regulations covering pre-market and post-market management
• Excellent written and verbal communication skills in English
• Proven problem-solving and strategic planning skills
• Team player with a proactive attitude and collaborative mindset

[Preferred Qualifications]

• Proficient in MS Office applications (Word, Excel, PowerPoint)
• Familiarity with Digital Medical Product regulations or post-market surveillance requirements

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