Regulatory Affairs Manager - Clinical Accessories

Job Description Summary This position provides strategic regulatory direction to the Clinical Accessories Business within Life Care Solution (LCS) 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 Clinical Accessories business in operations and strategic planning.

Job Description
Responsibilities :

• Provides high quality regulatory advice and is seen as a valued strategic partner to the business to optimize global medical device submission pathways.
• eads a team of regulatory professionals in execution of regulatory affairs tasks in support of the business
• Provides domain expertise in regulatory areas critical to the accessories business including international registrations, biocompatibility, electronic devices, reprocessing, medical software.
• Prepares regulatory submissions by working across the regulatory organization and cross functionally with other functions such as Engineering and Quality
• Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
• Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions and strategic planning with leadership
• Leads regulatory inspection support for the site, as well as support for regulatory inquiries from authorities related to adverse events or recalls.
• Supports and encourages a collaborative, inclusive, open and team based culture across his / her organization and the larger Regulatory Affairs organization
• Seeks out and implements proactive initiatives to improve and enhance the regulatory compliance and efficiency for the team and opportunities to learn in new scientific or technical areas important to the business.

Qualifications :

• Bachelor's Degree in a Scientific or Engineering discipline or a minimum of 10 years work experience.
• A minimum of 5 years Regulatory Affairs / Quality Assurance experience
• A 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
• Strong experience with management of regulatory projects in global regulatory organizations and working across different cultures

Desired Characteristics :

• People management or project management experience
• Advanced degree in scientific, technology or regulatory affairs disciplines
• Regulatory Affairs Certification (RAPS)
• Strong team leadership skills, facilitates teamwork, proven ability to lead, inspire and prioritize

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

GE 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: No