Manager Of Regulatory Affairs Jobs in Wisconsin

Job Title: Regulatory Affairs Manager Company: General Electric Company Location: Waukesha, WI Description: The Regulatory Affairs Manager provides subject matter expertise to ensure GE Healthcare (GEHC) establishes & implements best practices in the areas of advertising & promotional material and supplier quality. Lead global regulatory activities related to regulatory review and policies of advertising and promotional material and related processes. Develop and implement related regulatory guidance for global sales/marketing staff Provide regulatory support for cross-functional regulatory/marketing/legal teams and working groups. Review global advertising and promotional materials to ensure compliance with applicable laws and regulations. Support auditing of advertising and promotional materials to ensure compliance, partner with business and global counterparts to ensure compliance of emerging media (internet, online tools, etc), Support supplier quality in ensuring compliance with regulatory requirements, including procedure & work instruction development Analyze and communicate regulatory trends and their implications for GE Healthcare; develop & implement effective regulatory strategies, programs and processes to meet business objectives and ensure compliance with regulatory requirements Lead and support continuous improvement activities, including such areas as regulatory procedure development and documentation, standards compliance, and metrics development and implementation. Liaise with external regulatory bodies to guide input into regulatory strategies. Work closely with regulatory, engineering, marketing, legal, and other professionals across the company to develop & implement company-wide programs and processes for regulatory compliance. Work across GEHC to ensure a consistent approach to regulations is adopted throughout the business within areas of responsibility. Collect, summarize & analyze performance metrics to identify program weaknesses & drive improvements in procedures or oversight. Educate, train, & advise company professionals to ensure compliance with RA requirements. Qualifications/Requirements This position is open to internal and external candidates 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 & regulationsDemonstrated experience operating in a highly regulated environment; proven application of analytical skills in a regulatory environmenDemonstrated 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, etcDemonstrated project management skills; ability to prioritize, plan, evaluate & execute deliverables for established tactical goalDemonstrated ability to lead cross-functional, cross-business teamsAbility to influence and make recommendations at multiple levels of the companExcellent 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 requirementsExperience using spreadsheet and presentation softwarMust be willing to travel up to 15% of time.* You must be willing to take a drug test.* You must be willing to submit to a background investigation, including for example, verification of your past employment, criminal history, and educational background.* You must be legally authorized to work in the United States without work sponsorship at the time of hire.* You must submit your resume through gecareers.com or a job board to be considered for a specific job opening (internal candidates should apply through COS).* You must be willing to work out of a GE office in Waukesha, WI. GE will only employ those who are legally authorized to work. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.