Job Description Summary

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.

The Regulatory Affairs (RA) Training Manager is a pivotal role in the Regulatory Operations group and has responsibility for the management of Global QMS and non-QMS related training in Regulatory Affairs. The role is responsible for ensuring the timely administration of ComplianceWire for the Regulatory Affairs (RA) organization, managing the RA training matrix and QMS documents, ensuring RA compliance with training plans and assignments and managing RA QMS document lifecycles. The role is also responsible for creating onboarding plans for new starters across the Regulatory Affairs organization, owning and updating training materials for RA systems and delivering instructor-led trainings for RA systems when required.

Job Description

Responsibilities:

• Responsible for administering ComplianceWire for the Regulatory Affairs (RA) organization and ensures user training, access provision and user support.

• Ensures compliance of RA organization with QMS training plans and assignments.

• Responsible for the management of the RA training matrix for all RA groups.

• Responsible for the management of RA-authored QMS documents and issuance of associated training tasks.

• Management of onboarding plans for new starters across RA

• Ownership and management of RA systems training material developments.

• Delivery of instructor-led trainings for RA systems where appropriate.

• Responsible for root cause analysis and resolution of related incidents/deviations and CAPAs pertaining to RIM team-owned application and business processes.

• Runs metrics to report operating success and participating in evaluation and identification of areas of improvement.

• Opportunity to get involved in business administration for other systems managed by the Regulatory Information Management team and other initiatives led by the RIM team.

• Other relevant tasks based on person’s qualifications and experience, and current needs within function.

Required Qualifications:

• Experience in the Quality & Life Sciences Quality. Knowledge level is comparable to a Bachelor's degree from an accredited university or college (or a high school diploma with relevant experience).

• Experience of the pharmaceutical industry with direct experience in Regulatory Affairs, possessing a solid understanding of the pharmaceutical regulatory affairs process.

• Proven track record of managing and developing global training programs/projects or e-learning solutions.

• Proven ability to apply innovative techniques to ensure seamless user experience and training effectiveness is of a high standard.

• Proven track record of identifying training needs and engaging with internal stakeholders.

• Experience with tool based and process-based training.

• Experience with designing technical course materials.

• Familiarity with data systems and modern educational techniques.

• Experience with HTML5, SCORM, AICC, xAPI and relevant e-learning standards.

• Exceptional communication and presentation skills in English.

Skills:

• Excellent time management and administrative skills with a keen attention to detail.

• Effective analytical skills and the ability to summarize information and offer solutions.

• Positive and outgoing personality.

• After receiving intensive training, be able to work independently in a structured manner.

• Knowledge of Veeva Systems will be an asset.

• Experience with Veeva Vault/Lorenz Docubridge or other related DMS and QMS systems.

• An interest in new and emerging learning development theories and practices.

• Solution mindset and familiarity with lean approach.

• Additional certification in instructional designing and training is a plus.

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.

Behaviors

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.

Total Rewards

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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Additional Information

Relocation Assistance Provided: No