Regulatory Affairs Specialist

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Description:

Regulatory Affairs Specialist

3M Health Care is now Solventum

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

The Impact You’ll Make in this Role

As a Regulatory Affairs Specialist, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

• Manage and execute new submissions and renewal activities for medical device licenses, as well as post‑approval regulatory maintenance for all Korea products.
• Serve as a core team member for the KR MDR project, supporting long‑term regulatory strategy and execution through early engagement and license lifecycle continuity.
• Perform license maintenance activities while ensuring compliance with internal regulations and Korean health authority requirements.
• Coordinate with internal cross‑functional stakeholders (Global Regulatory Affairs, Quality, Supply Chain, and Commercial teams) to support regulatory deliverables and timelines.
• Prepare, compile, submit, and maintain regulatory documentation in accordance with MFDS requirements.
• Monitor changes in Korean regulations and assess potential impacts on existing licenses and future submissions.

Your Skills and Expertise 

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Bachelor’s degree in a scientific, engineering, or related field; Pharmacist license is preferred.

In addition to the above requirements, the following are also required:

• At least 5 years of experience in Regulatory Affairs for medical devices, preferably with MFDS regulations.
• Hands‑on experience with medical device license submissions and license maintenance activities.
• Strong knowledge of Korean medical device regulations and product lifecycle management is preferred.
• Strong project management skills with the ability to manage multiple regulatory activities independently.
• Excellent communication skills in Korean and English (written and verbal).

Additional qualifications that could help you succeed even further in this role include:

• Strong regulatory and compliance mindset with accountability
• High attention to detail and accuracy
• Ability to work independently and manage priorities effectively
• Collaborative approach with cross‑functional teams
• Proactive problem‑solving and risk management

Work location: Seoul, Korea

·       Hybrid (Onsite and Remote): Eligible

Travel: May include up to 20% domestic

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Supporting Your Well-being 

Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope. 

   

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process.  Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.

Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.

Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

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