Posted Position Title Regulatory Affairs Manager-HC

Job Number	1784017
Business	GE Healthcare
Business Segment	Healthcare Quality
Career Level	Experienced
Function	Quality
Function Segment	Regulatory Affairs
Location(s) Where Opening Is Available	United States
U.S. State, China or Canada Provinces	Wisconsin
City	Waukesha
Postal Code	53188-1696
Relocation Expenses	No
Role Summary/Purpose	GE is an equal opportunity employer, offering a great work environment, challenging career opportunities, professional training and competitive compensation. The Regulatory Affairs (RA) Manager – Product provides subject matter expertise and may directly or indirectly lead a team of experts to ensure that GEHC establishes and implements best practices in the area of Pre-Market regulatory submissions and new product development.
Essential Responsibilities	• File and maintain regulatory deliverables, • Actively participate as team member on all assigned new product introductions. • Create regulatory compliance / project plan in collaboration with Region RA to ensure all requirements are met for country submissions; work with relevant personnel to ensure accurate, complete, timely input is provided for submissions. • Create and file submissions; communicate with authorities for these submissions. • If specific country testing is needed, work with Region RA, and arrange for test devices and support as needed. • Review and approve advertising and promotion material ensuring it is consistent with approved claims for regulated products. • Review changes in existing products to determine need for new/revised submissions or document reason for no submission • Communicate changes in existing products to Region RA for determination of the need for new/revised licenses or registrations; partner with Region RA for countries with license expiration requirements, to establish plan and deliverables for timely submission for renewal of license. • Identify any clinical data requirements for product licensing globally and insure the requirements are documented in the compliance plan; provide RA oversight to clinical studies. • May have GE Healthcare signature authority for submissions and other regulatory documents. • Support local regulatory authority / notified body inspections as required. • Identify regulatory trends and their implications for GE Healthcare; analyze & communicate proposed, new or changing requirements; communicate and track information for country. • As appropriate, recruit, mentor, coach & train direct and indirect reports on activities within areas of responsibility
Qualifications/Requirements	1. Bachelor’s Degree & minimum of 7 years experience in the medical device or pharmaceutical industry or with medical product regulatory agencies; OR minimum of 11 years progressive regulatory affairs experience in medical device or pharmaceutical industry or with medical product regulatory agencies, including knowledge & experience applying drug or device laws & regulations. 2. Demonstrated experience operating in a highly regulated environment; proven application of analytical skills in a regulatory environment 3. Demonstrated knowledge of regulatory issues, and experience interfacing with local & international regulatory bodies, such as FDA, European competent authorities & notified bodies, Health Canada, SFDA, KFDA, MHLW, etc. 4. Demonstrated project management skills; ability to prioritize, plan, evaluate & execute deliverables for established tactical goals 5. Demonstrated ability to lead cross-functional, cross-business teams. 6. Ability to influence and make recommendations at multiple levels of the company 7. 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. 8. Experience using spreadsheet and presentation software 9. Must be willing to travel up to 15% of time.
Additional Eligibility Qualifications	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 background investigation and drug screen.
Desired Characteristics	1. Advanced degree in scientific, technology or legal disciplines. 2. Regulatory Affairs Certification (RAPS). 3. Knowledge of Quality Management Systems (QMS). 4. Experience working across cultures/countries/sites. 5. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment. 6. Strong problem solving and negotiation skills. 7. Demonstrated ability to work well independently & in a team setting. 8. Demonstrated ability to drive change, challenge the status quo and champion new activities, stimulating others to change and manage implementation effectively. 9. Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies. 10. Prior GEHC experience