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Regulatory Affairs Manager - ARC

Employer
GE Healthcare
Location
Madison
Salary
Competitive

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Job Description Summary This position provides strategic regulatory direction to the Anesthesia and Respiratory Care (ARC) business regarding regulatory requirements for product launch, submissions and postmarket compliance. He / she leads a team of regulatory professionals in preparing regulatory strategies, premarket submissions, postmarket reporting and responses to regulator inquiries, regulatory intelligence, regulatory requirements flow-down and postmarket compliance (e.g. advertising / promotion, etc.), as applicable. Supports the cross-functional business leadership team for the ARC business in operations and strategic planning.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 leadership and strategic direction for Monitoring Solutions regulatory programs, including global RA support for registration planning, submissions, notified body and quality system audits, and program implementation across a cross-functional team with communication to leadership. Supports compliance of premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally.Develops regulatory strategies to help optimize 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.Explains information clearly with the right level of detail for the audience, and works to understand a situation, potential risks, and develop possible solutions; brings team members to consensus around topics within the field.Recognizes when additional support from senior levels within RA is needed to ensure sound decisions are made and risks are minimized.Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytical thinking to solve problems. May use multiple internal sources outside of own team to arrive at decisions.Assesses changes in existing products and determines the need for new / revised licenses or registrations.Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.Contributes to writing and editing technical documentsResearches, analyzes, integrates and organizes background information from diverse sources for regulatory submissionsUnderstands and applies regulatory requirements and their impacts for submissions and pre- and post-market compliance. Required Qualifications Bachelor's Degree in a Scientific or Engineering discipline or High School a minimum of 10 years work experience.A minimum of 5 years Regulatory Affairs / Quality Assurance experienceA minimum of 5 years' experience in the medical device or pharmaceutical industry A minimum of 3 years experience of regulatory project management/program management and regulatory agency interactions Experience preferred with high risk or life supporting, life-sustaining productsDeep domain expertise in regulatory topic areas such as biocompatibility, reprocessing, electrical devices, software, cybersecurity.Strong experience with management of regulatory projects in global regulatory organizations and working globally and across different cultures Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer's requirements.Desired Characteristics People management experienceAdvanced degree in scientific, technology or regulatory affairs disciplinesRegulatory Affairs Certification (RAPS)Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies.Strong team leadership skills, facilitates teamwork, proven ability to lead and inspireAssertive and willing to make decisions and assign clear prioritiesOur 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-JC1GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer . 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.GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).Relocation Assistance Provided: Yes

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