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Job Description Summary

Responsible for leading a team of Quality and Regulatory Affairs professionals for GE HealthCare’s International Developed Markets Region (Europe, Russia, Australia, New Zealand, Japan).

Job Description

Responsibilities:

• Member of the International Region and Global Quality and Regulatory Affairs Senior Leadership Teams

• Partnering with the VP, Quality and Regulatory for Developing Markets to provide strategic direction to the International Region business leadership, advising on pre-market and post market regulatory and quality matters regarding the developed markets and delivering world-class service across the total product lifecycle for the Region

• Ensure ongoing compliance with the Quality Management System requirements for International Developed Markets Sales and Service organizations, including timely investigations and CAPA, training, service records quality, recall execution

• Ensure readiness and effective management of internal and external quality audits and manage internal audit program within International Region Developed Markets

• Manage distributor and importer regulatory responsibilities and local regulatory requirements for the International Developed Markets (e.g. product licenses, sale of approved devices, registration of local sales / service site, advertising and promotion)

• Define and monitor country specific pre- and post-market regulatory requirements for the International Developed Markets

• Ensure timely and accurate pre-market submissions, consistent with business strategy

• Ensure compliance with applicable advertising and promotion requirements in the Region

• Ensure compliance with post-market regulatory requirements, including timely and accurate reporting of adverse events and recalls and responses to regulator inquiries

• Work closely with senior executives (e.g. Chief Quality & Regulatory Officer, International Region CEO, Quality, Legal, Marketing, Sales, Service) to develop and implement regulatory strategies, policies and positions that are consistent with the business vision and country-specific regulatory requirements; provide proactive regulatory and quality advice, expertise and data on Region basis to guide management and drive appropriate decisions

• Comment on, and ensure appropriate company review of draft legislation, regulation, and guidance affecting GE Healthcare

• Proactively monitor regulatory environment and ensure effective flow-down and organizational readiness for changes in regulations within the Region

• Analyze and share regulatory intelligence and provide impact assessment and actions required to ensure compliance to minimize and eliminate impact to business continuity

• Lead Regulatory and Quality colleagues across GE HealthCare to ensure consistent approach to regulatory authorities is adopted throughout the business

• Recruit, mentor and train direct and indirect reports on activities within areas of responsibility

• Coach Regulatory and Quality Leaders across her/his own organization and across the Global Regulatory Affairs and Quality organization to develop and execute effective strategies that meet applicable regulatory requirements and business objectives

Qualifications:

• Bachelor Degree in Science, Engineering, Legal or Regulatory Affairs (or other related field) & minimum of 10 years’ experience in the medical device industry or with medical device regulatory agencies; OR minimum of 16 years progressive quality/regulatory affairs experience in the medical device industry or with medical device regulatory agencies, including knowledge and experience applying device laws and regulations for product registration, Quality Management System requirements, inspections, adverse event reporting and product recalls

• Minimum of 5 years proven leadership experience including hiring, training, coaching and performance management activities

• Extensive knowledge of European regulatory requirements Extensive experience guiding and managing complex pre-market and post-market regulatory matters globally

• Demonstrated experience interfacing with regulatory bodies, such as European Competent Authorities and Notified Bodies

• Extensive experience in shaping and influencing regulations and guidance documents globally, working with industry groups, regulators and standards associations

• Strong experience with Quality Management System development and application and with leading external and internal audits

• Strong problem solving and negotiation skills with the ability to develop and implement complex influencing and negotiating strategies that demonstrate political awareness

• Ability to influence and make recommendations at all levels of the company. Demonstrated project management skills to establish strategic goals and to prioritize, plan, delegate and evaluate deliverables

• 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

• Prior experience using spreadsheet and presentation software

• Must be willing to travel up to 25% of time

Desired Characteristics:

• Quality System and/or auditor certifications; RAC (EU) Advanced degree in Regulatory Affairs, or a scientific, technology or legal discipline

• Demonstrated experience with a new product introduction process (i.e. new product launches), including medical device software applications and platforms

• Demonstrated experience working with industry trade associations and standards organizations in shaping regulatory and technical requirements

• Experience with advertising and promotion regulations and best practices

• Experience working across cultures/regions/sites

• Demonstrated ability to drive change, challenge the status quo and champion new activities, stimulating others to change and manage implementation effectively

Additional Information

Relocation Assistance Provided: No