Together, we can beat cancer.

At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions.

We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

If you want to be part of this important mission, we want to hear from you. 

The Regulatory Affairs Analyst develops strategies, evaluates product changes, prepares submissions, ensures compliance, supports inspections, and maintains KGMP certifications, requiring 5-6 years of medical device regulatory experience and strong communication skills.

Responsibilities:

• Develops regulatory strategies and assists in navigating the submission pathway
• Evaluates changes to existing products to determine the need for new registrations or license variations.
• Organizes renewal submissions based on business requirements to ensure business continuity
• Provides regulatory input throughout the product development cycle and ensures compliance with relevant standards.
• Collaborates with a cross functional team to achieve regulatory excellence.
• Reviews and approves marketing materials to ensure they align with approved claims and/or regulatory requirements.
• Evaluates the reportability of adverse events and performs post-market reporting in accordance with national regulations.
• Identifies issues affecting project progress and collaborates with management to propose solutions for project acceleration or correction.
• Keeps abreast new regulatory requirements and organize regulatory intelligence for impact assessment in South Korea.
• Fosters effective and transparent communication within the Regulatory Affairs team and with other relevant stakeholders and departments.
• Provides support during regulatory inspections and audits as needed such as ISO 13485, GIP, KGMP, etc.
• Ensures accurate documentation in accordance with Quality Management System (QMS) requirements.
• Develops and implements strategic plans for Korea Good Manufacturing Practice (KGMP) and oversees the maintenance of KGMP certifications.
• Coordinates with overseas manufacturing sites to obtain necessary KGMP documents and dossiers in a timely manner.

Qualifications/Requirements:

• Minimum 5-6 years working experience as regulatory affairs in medical device company
• Demonstrated proficiency with Business Tools such as MS Office word, excel, powerpoint applications.
• Bachelor's degree in science, engineering, medical or related subject
• Ability to communicate effectively in English (both written and oral).
• Korea MFDS experience is preferred
• Korea RA level 2 certification is preferred

Varian is required to comply with all local and applicable regulations that may be associated with vaccine requirements for certain roles.