Sr. Lead Specialist, Regulatory Affairs

1 week ago

Shanghai, Shanghai, China GE HealthCare Full time
Job Description SummaryProvides 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. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.

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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Job Description

Roles and Responsibilities

  • Provides the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements
  • Leads regulatory team/ resource to ensure timely product registration, regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance
  • Manage medical device registration whole processes from project kick-off to product launch; To actively contact with external parties such as testing lab, government agency to accelerate the registration processes
  • Works with a cross functional team closely to ensure the registration files quality and completion on time
  • Assesses changes in existing products to and determines the need for new / revised licenses or registrations
  • Develops plan for timely submission of extension registrations per business plan, to ensure continued product supply
  • Contributes to writing and editing technical documents
  • 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
  • To manage existing product license
  • To ensure label and IFU regulatory compliance

Required Qualifications

  • 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;
  • English communication in speaking, listening and writing;
  • Good communication skills;
  • 5+ years working experience as regulatory affairs in medical device company is preferred.

Desired Characteristics

  • Minimum of 4 years' experience medical device regulatory affairs.
  • 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.

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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