2141975
**Business** GE Healthcare
**Business Segment** Healthcare Quality
**Posted Position Title** Regulatory Affairs Leader\-HC
**Career Level** Experienced
**Function** Quality
**Function Segment** Regulatory Affairs
**Location\(s\) Where Opening Is Available** Saudi Arabia
**City** Riyadh
**Postal Code** 11391
**Relocation Expenses** No
**Role Summary/Purpose** The Regulatory Affairs Manager provides subject matter expertise and may lead a team of regulatory affairs professionals to ensure GEHC establishes & implements best practices within the assigned area of responsibility \(technical standards, laws and regulations, regulatory programs, etc\)\.
**Essential Responsibilities** • 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\. • Collect, summarize & analyze performance metrics to identify program weaknesses & drive improvements in procedures or oversight\. • Work across GEHC to ensure a consistent approach to regulations is adopted throughout the business within areas of responsibility\. • Educate, train, & advise company professionals to ensure compliance with RA requirements\. • As appropriate, recruit, mentor, coach & train direct and indirect reports on activities within areas of responsibility Quality Specific Goals: 1\. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position 2\. Complete all planned Quality & Compliance training within the defined deadlines 3\. Identify and report any quality or compliance concerns and take immediate corrective action as required 4\. Maintain up\-to\-date knowledge and understanding of current regulatory requirements within area of responsibility 5\. Effectively implement & manage programs and processes to meet regulatory requirements within area of responsibility
**Qualifications/Requirements** Required Qualifications: 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\. Preferred Qualifications: 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\.
**Desired Characteristics** N/A