Lead RA Specialist

Job Description SummaryWe are the doers. The leaders. The makers. The change-bringers. We are all different, uniting to solve the world’s toughest challenges. Our teams are hungry to make history, acting with integrity to relentlessly improve people’s lives. With every weld, every sale, and every code we write we keep the world in motion. It’s time to stop dreaming about the future; let’s build it together.
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.
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

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Job Description

[HR Talk]

GE HealthCare에서 RA 업무를 담당하실 6년이상의 과차장급을 채용합니다. 국내외 의료기기 회사에서 Regulatory 업무를 담당해보신 경력자를 우대하며 Global과의 커뮤니케이션이 잦은 포지션이라 영어 소통이 원활하신 분을 우대합니다.

Essential Responsibilities:

• Provides regulatory input during product development and ensure product compliance
• Develops regulatory strategies and help navigate regulatory submission route map
• Works with a cross functional team to achieve regulatory excellence
• Reviews and assesses changes in existing products to determines for new registration and/or license revision
• Plans for renew submission per business needs, to ensure product supply continuity
• Reviews and approves advertising material to ensure compliance with approved claims and/or other regulatory requirements. 
• Performs environment scan for new regulatory requirements and organize regulatory intelligence for impact assessment
• Supports regulatory inspections/audit as required. 
• Assess adverse event reportability and perform post market reporting as per country regulations.
• Identify issues impacting project progression and work with manager to recommend improvements to correct or accelerate project progression
• Establish effective and clear communication within RA and other relevant stakeholder and functions
• Ensure proper documentation in compliance with QMS requirement
• Set the strategic plan for KGMP (Korea Good Manufacturing Practice) and execute KGMP certs maintenance
• Communicate with the overseas manufacturing sites to get the required KGMP documents and dossiers on time
   

Qualifications/Requirements:

• Min 6+ 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 Diversity

GE 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.

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