Regulatory Affairs Specialist

서울시
정규직
풀타임

1개월 전

Job Description Summary Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Developing conceptual knowledge of professional discipline. May include support roles with specialized expertise or technical knowledge in broad area.•The individual would be working with a team of Regulatory Affairs professionals to ensure GEHC Korea achieves compliance to applicable regulations. The individual would be involved with regulatory activities in the areas such as premarket submissions, post-market reporting, regulatory intelligence, advertisement review, product compliance and KGMP certification.Job DescriptionHR TalkGE HealthCare에서 RA 업무를 담당하실 3년이상의 대리과장급을 채용합니다. 국내외 의료기기 회사에서 Regulatory 업무를 담당해보신 경력자를 우대하며 Global과의 커뮤니케이션이 잦은 포지션이라 영어 소통이 원활하신 분을 우대합니다.Essential Responsibilities:1. Provides regulatory input during product development and ensure product compliance
2. Develops regulatory strategies and help navigate regulatory submission route map
3. Works with a cross functional team to achieve regulatory excellence
4. Reviews and assesses changes in existing products to determines for new registration and/or license revision
5. Plans for renew submission per business needs, to ensure product supply continuity
6. Reviews and approves advertising material to ensure compliance with approved claims and/or other regulatory requirements.
7. Performs environment scan for new regulatory requirements and organize regulatory intelligence for impact assessment
8. Supports regulatory inspections/audit as required.
9. Assess adverse event reportability and perform post market reporting as per country regulations.
10. Identify issues impacting project progression and work with manager to recommend improvements to correct or accelerate project progression
11. Establish effective and clear communication within RA and other relevant stakeholder and functions
12. Ensure proper documentation in compliance with QMS requirement
13. Set the strategic plan for KGMP (Korea Good Manufacturing Practice) and execute KGMP certs maintenance
14. Communicate with the overseas manufacturing sites to get the required KGMP documents and dossiers on timeQualifications/Requirements:

Min 3+ years working experience as regulatory affairs in medical device company
Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
Bachelor’s degree or above major in material, engineering, biotechnology, pharmacy, or related subject
Ability to communicate effectively in English (both written and oral).
Good communication skills.
Regulatory Affairs Certification. (RAPS) is preferred
Korea MFDS experience is preferred

Inclusion and DiversityGE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.#LI-JJ1#LI-ONSITE#LI-HYBRIDAdditional InformationRelocation Assistance Provided: No

GE HealthCare

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