Ra Lead Specialist

**Job Description Summary**: This position provides guidance to the growing ASEAN and Korea business, primarily support ASEAN. He/she works within a team of Regulatory Affairs professionals to ensure GEHC establishes best practices in compliance with regulatory requirements. The Regulatory Affairs Lead Specialist will be involved with regulatory activities in the areas such as premarket submissions, post-market reporting, regulatory intelligence, regulatory requirements, product labeling compliance, etc.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. 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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**Essential Responsibilities**:

- Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets
- Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc), product claims and country regulatory dependencies to ensure optimized sequencing for submissions,
- Works with a cross functional team to prepare and submit regulatory submissions to regulatory authorities for the purpose of obtaining authorization for market launch.
- Assesses changes in existing products to and determines the need for new / revised licenses or registrations.
- Develops plan for timely submission of renewal registrations for applicable countries per business plan, to ensure continued product supply in those countries.
- Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions
- Understands and applies regulatory requirements and their impacts for submissions
- Ensures compliance with pre
- and post-market product approval requirements
- Supports regulatory inspections as required.
- Assesses adverse events and field actions for reportability to regulatory authorities and prepares and submits reportable events and recalls in a timely manner to regulatory authorities, as per country regulations.
- 11. Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager
- 12. Assess and design regional registration pathway for service upgrades and accessories

**Qualifications/Requirements**:

- Bachelor's Degree or a minimum of 5 years relevant work experience.
- Able to tailor communication path to better meet the needs of the situation.
- Working knowledge of country / region regulations and standards
- Able to identify and monitor for changes to requirements
- Highest integrity in all interactions

**Desired Characteristics**:

- Minimum of 5 years experience medical device quality and regulatory affairs.
- Advanced degree in scientific, technology or legal disciplines
- Ability to work independently in fast-paced environment with little supervision.
- Ability to adapt to constant change and influence positive change effectively.
- Team-oriented and responsive to customer needs.
- Attention to Detail and Results-Oriented.
- Ability to understand technical documentation and execute associated procedures
- Ability to learn regulations effectively
- Applies several sets of requirements together balancing strategy effectively

**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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