[담당업무]

[Summary of the Role]
As a Regulatory Affairs Professional, you will play a key role in ensuring regulatory compliance throughout the product lifecycle of ultrasound systems, catheters, and transducers — including those with AI-powered features. He or she will collaborate with cross-functional teams and international regulatory stakeholders to support global product registrations and enable market access. This role is especially critical in driving regulatory strategy and execution for catheter-related registrations and next-generation systems incorporating artificial intelligence.

[Job Scope/ Responsibilities]
- Lead or support regulatory submissions for ultrasound systems, transducers, and catheters in global markets (e.g., USA, EU, etc.).
- Develop regulatory strategies for AI-enabled features and ensure compliance with emerging global regulations on Software/AI as a Medical Device.
- Collaborate with R&D, Quality, and Clinical teams to integrate regulatory requirements throughout the product development lifecycle.
- Prepare and compile high-quality regulatory submissions (e.g., Technical Documentation, 510(k), etc.).
- Monitor and interpret evolving global regulatory requirements and communicate updates to internal teams.
- Serve as liaison with international regulatory authorities or regional RA counterparts to address inquiries or deficiencies.
- Support regulatory aspects of audits and inspections (e.g., ISO 13485, MDSAP, FDA, KGMP, etc.).
- Contribute to risk assessments and design documentation reviews to ensure regulatory compliance.
- Provide regulatory input to product lifecycle planning and change management processes.

[근무부서 및 직급/직책]

직급/직책: 대리, 과장, 차장

[자격요건]

경력: 경력 5년↑
학력: 대졸
직무기술: Regulatory Affairs Professional, RA

- Advanced Level of English

- Regulatory affairs experience for FDA 510(k) clearance and AI/ML-based features

- 5 ~ 10 years of experience in Regulatory Affairs in the medical device industry.

- Excellent communication skills, with the ability to draft and present regulatory documents in English.

- Bachelor’s degree (or higher) in Biomedical Engineering, Electrical/Electronic Engineering, or a related field.

- Knowledge of regulatory frameworks and documentation requirements for AI/software-enabled medical devices (e.g., SaMD, AI/ML-based features).

- Strong understanding of global medical device regulations and standards (e.g., MDR, FDA 21 CFR, IEC 60601 series, ISO 13485, ISO 14971, ISO 10993)

- Hands-on experience preparing submission packages and managing communications with regulatory bodies or regional RA partners.

- Familiarity with registration procedures and requirements in the EU, US, and other global markets.

- Demonstrated ability to manage multiple regulatory projects and meet deadlines.

- Experience supporting external audits and regulatory inspections.

- Detail-oriented with strong analytical and organizational skills.

- Experience with regulatory documentation for AI/ML models.

- Ability to provide regulatory input to product lifecycle planning and communicate regulatory information to stakeholders.

- Proven experience in regulatory submissions for invasive Class III or higher classified devices, such as catheters, as well as ultrasound systems and accessories is preferred.

- Experience with regulatory documentation for catheters.

[우대사항]

전공계열: 공학계열, 의/약학계열
외국어: 영어 회화가능,독해가능,작문가능