Sr. Regulatory Affairs Specialist at Boston Scientific Corporation Malaysia

Seoul, , South Korea -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

0.0

Posted On

02 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Submission Management, Regulatory Compliance, Medical Device Regulations, Problem-Solving, Strategic Planning, Team Player, Collaboration, Communication Skills, Quality Training, Digital Medical Product Regulations, Post-Market Surveillance, MS Office Proficiency, Biomedical Engineering, Life Sciences, Product Lifecycle Management

Industry

Medical Equipment Manufacturing

Description

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 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 Participate in global and local projects to ensure alignment with global processes and adherence to local regulatory requirements 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 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 Proficient in MS Office applications (Word, Excel, PowerPoint) Familiarity with Digital Medical Product regulations or post-market surveillance requirements

Responsibilities

Develop and prioritize regulatory strategies for product approvals and ensure timely submissions through high-quality applications. Collaborate with global teams and serve as a regulatory consultant to support business objectives and compliance throughout the product lifecycle.