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Boston Scientific Sr Regulatory Affairs Specialist 
South Korea, Yongin-si 
861468033

Yesterday

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