Program Manager, Regulatory Affairs, Thailand

6 days ago

กรงเทพมหานคร, Thailand GE HEALTHCARE Full time

**Job Description Summary**: Provides regulatory strategy and direction to the Thailand 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 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.

**Roles and Responsibilities**:

- Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally
- Developing in-depth knowledge of country regulation. Uses prior experience and acquired expertise to execute functional policy/strategy.
- Ability to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about regulations and product registration timelines. Explains complex information to others in straightforward situations.
- Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems.
- Develop plan for product registration as per business plan, to ensure market access for our products
- Understands and applies country regulatory requirements and their impacts for submissions
- Ensures compliance with pre
- and post-market product approval requirements
- Support regulatory inspections as required.
- Assess adverse events and field actions for reportability to regulatory authorities and submit post market reporting to regulatory authorities, as per country regulations.

**Required Qualifications**:

- Bachelor's Degree or a minimum of 5 years relevant work experience.
- Ability to communicate effectively in English - reading and good wring skills
- 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**:

- Demonstrated ability to analyze and resolve problems.
- Ability to document, plan, market, and execute programs.
- 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.

LI-BA1

LI-ONSITE

LI-HYBRID

**Additional Information**:
**Relocation Assistance Provided**:No

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