Regulatory Specialist I

[An exciting opportunity]

Boston Scientific Korea is seeking a highly motivated and responsible 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.

[Purpose Statement]

The purpose of this role is to provide regulatory expertise to ensure rapid and timely approvals for electrophysiology products in BSC, complying with local and global regulatory requirements. This role offers the opportunity to work cross-functionally and contribute to bringing innovative medical technologies to Korean patients.

[Key Responsibilities]

1. Regulatory Strategy & Submission Management

• Prioritize and develop strategies for product registrations, including license renewal, license re-evaluation, and KGMP certifications (excl. KGMP recertification), for assigned product lines.
• Ensure timely submission and approval of high-quality regulatory applications in alignment with planned or committed timelines.
• Collaborate with global and regional RA peers to align regulatory strategies and provide timely regulatory support.
• Serve as a regulatory consultant to the marketing team by providing input on regulatory matters to support business objectives.

2. Compliance Across Product Lifecycle

• Ensure regulatory compliance throughout the product lifecycle, including labeling, advertising/promotional material review, and management of product changes.
• Complete mandatory quality training within designated timelines and ensure full compliance with internal quality systems, policies, and applicable local regulations.
• Support internal and external audits related to regulatory affairs.

3. Regulatory Intelligence & Policy Engagement

• Monitor emerging regulatory trends and assess their potential impact on organizational processes; proactively share relevant updates with internal stakeholders.
• Establish and maintain relationships with local medical device industry associations and collaborate with industry peers to respond to regulatory authorities and influence local 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 by ensuring quality submissions, actively responding to MFDS requests, and providing scientific justification for regulatory challenges, including alternative solutions when appropriate.
• Establish and maintain relationships with the local medical device industry and collaborate with industry peers to respond to regulatory authorities and influence local policy development.

[Required Qualifications]

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field
• Minimum 3 years of hands-on experience in Regulatory Affairs within the medical device industry
• Knowledge and understanding of medical device regulations related to BSC product launch.
• Excellent written and verbal communication skills in English.
• Problem solving and strategic planning skills.
• Team player with a proactive attitude and problem-solving mindset

[Preferred Qualifications]

• Proficiency in MS Office applications (Word, Excel, PowerPoint)
• Familiarity with digital health product regulations or post-market surveillance activities

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