Post Market CoE RA Lead Specialist

Job Description Summary

Provides regulatory strategy and direction to the business regarding healthcare regulatory requirements for post market 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.

Job Description

Roles and Responsibilities

• Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for post market compliance, working closely with healthcare regulatory bodies globally
• Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy.
• A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations.
• Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance.
• Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.
  
  

Required Qualifications

• Bachelors degree from an accredited university or college ( or a high school diploma with relevant experience) with minimum 7+ years of experience in the Quality & Regulatory Affairs
  
  

Desired Characteristics

• Bachelor’s degree in engineering, biomedical sciences, or a related discipline preferred. An equivalent combination of education and experience may be considered.
• Minimum of three years of experience in medical device manufacturing, preferably within quality control or regulatory affairs.
• Strong understanding of medical device regulations and compliance requirements.
• Knowledgeable in lean six sigma principles and project management methodologies.
• Excellent problem-solving skills with a focus on root cause analysis and corrective action implementation.
• Proven ability to work collaboratively across multifunctional teams.
• Excellent Interpersonal and communication skills with the ability to convey complex information clearly and concisely.
• Proficiency in Microsoft Office Suite, particularly Excel and PowerPoint.
• Ability to travel domestically and internationally as needed (approximately 10%).
  
  

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.

Additional Information

Relocation Assistance Provided: No

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