Boston Scientific Sr Regulatory Affairs Specialist 

South Korea, Yongin-si 

861468033

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.

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