Specialist/Senior Specialist, Regulatory Affairs

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

*** This position is part of Varian Medical Systems Korea and works closely as one team with Siemens Healthineers.***

***본 채용공고는 Varian Medical Systems Korea 소속 포지션입니다.***

Job Description Summary: Analyzes the requirements and prepares product related regulatory submissions.

Responsibilities:  

• Develop regulatory strategies and manage hands-on preparation and submission of dossiers for new registrations, variations, and supplements to obtain necessary approvals. 

• Oversee QA-related responsibilities, including medical device importer obligations, KGMP/ISO 13485 compliance, and internal and external audits. 

• Monitor and analyze regulatory requirements in South Korea, determine their applicability to company products and operations, communicate their impact to management and relevant teams, and ensure regulatory compliance. 

• Provide regulatory input & collaborate with the internal teams throughout the product lifecycle to ensure local compliance, prevent regulatory gaps, and accelerate product registration and market launch. 

• Proactively identifying potential regulatory risks and proposing mitigation strategies to ensure compliance and minimize business impact. 

• Review and assess product labeling, packaging, and promotional/marketing materials to ensure compliance with relevant local regulations, codes, and company policies. 

• Manage post-market regulatory activities, including adverse event reporting (local and foreign AER), product recalls, corrective/preventive actions (CAPA), and other post-market surveillance requirements. 

• Represent the company in government and industry meetings, forums, audits, and lobbying activities. 

• Lead process improvements and productivity initiatives for regulatory operations in South Korea. 

• Support regulatory compliance for the Mongolia market. 

Qualifications/Requirements 

• Bachelor’s degree or equivalent in a related field, with 4 years of relevant experience. 

• Experience in high-risk medical device (Class III) under Medical Device Act 

• Experience with KGMP onsite audit 

• Familiar with Digital Medical Products Act (DMPA) is a plus  

• Able to manage projects with attention to detail, communicate effectively across all levels, and escalate issues proactively to ensure timely resolution. 

• Proficient in spoken and written English 

Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Healthineers’ specific businesses, please visit our company page here.

As an equal opportunity employer, we welcome applications from individuals with disabilities.

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