Regulatory Affairs Specialist – Solventum

Regulatory Affairs Specialist roles are crucial for bringing groundbreaking healthcare solutions to market safely and efficiently. Solventum, a premier global healthcare innovator with a rich legacy of solving big medical challenges (formerly part of 3M Health Care), is currently seeking a dedicated professional to join our team in Seoul, South Korea. This hybrid role offers an incredible opportunity to manage product registration, interface with international regulatory bodies, and ensure compliance for a diverse medical portfolio.

Role Overview

At Solventum, we put people at the heart of every healthcare innovation. As a Regulatory Affairs Specialist, you will play an essential part in securing timely regulatory approvals for our advanced medical solutions. You will work within a collaborative environment, bridging the gap between cutting-edge engineering and the evolving demands of local healthcare laws.

Core Responsibilities

1. Prepare, compile, and submit high-quality regulatory dossiers for new medical products and variations to the South Korean Ministry of Food and Drug Safety (MFDS).

2. Monitor and interpret changing national and international biomedical standards published by entities like the World Health Organization (WHO) to adapt local go-to-market strategies.

3. Collaborate seamlessly with cross-functional global teams, including quality assurance, clinical research, and product marketing.

4. Maintain accurate life-cycle documentation, ensuring full audit readiness at all times.

Also Check: Clinical Research Associate – AstraZeneca

Qualifications

1. Education: Bachelor’s degree or higher in Life Sciences, Pharmacy, Bioengineering, or a related technical discipline.

2. Experience: A minimum of 3 to 5 years of proven experience handling medical device or pharmaceutical regulations in South Korea.

3. Language Skills: Fluency in both Korean and English is required for navigating global documentation and local agency conversations.

4. Competencies: Exceptional project management skills and deep familiarity with South Korean medical compliance pathways.