6 days old

China Regulatory Affairs Leader

General Electric
Beijing, Beijing
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**Role Summary:**

Leads the regulatory function for one or more medical device modalities and/or pharmaceuticals and/or countries / regions within GE Healthcare, with overall responsibility for delivering a world-class regulatory service to the business and ensuring consistent, compliant best practices in regulatory processes are applied across GE Healthcare

**Essential Responsibilities:**

Active partner on the extended staff of modality and / or region business leaders.

1. Work closely with senior business executives (e.g. CQO, P&L CEO, Quality, Legal, Marketing, Engineering, Manufacturing, Service) to develop and implement regulatory strategies, policies and positions consistent with the business vision and global regulatory requirements; provide proactive regulatory advice, expertise & data on a global basis to guide management & drive decisions

2. Monitor the external landscape to formulate regulatory strategies and take into consideration the impact of business decisions; work closely with regulatory bodies globally

3. Continuously review and put strategies in place to improve existing processes and champion implementation of new initiatives across the GEHC regulatory function to ensure consistency, compliance and best practice

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

5. Share regulatory intelligence for wider dissemination and impact assessment; provide regulatory data for repository

6. Build global network of regulatory professionals across the company; lead regulatory colleagues across GEHC to ensure a consistent approach to regulatory authorities is adopted throughout the business

7. Recruit, mentor, coach and train direct and indirect reports on activities within areas of responsibility

8. Coach RA Leaders across his/her own organization and across the RA organization to develop effective regulatory strategies that meet business goals

9. Identify, assess and manage global regulatory risk proactively


1. Bachelor Degree in Science, Engineering, Regulatory Affairs (or other related field) & minimum of 7 years experience in the medical device or pharmaceutical industry or with medical product regulatory agencies; OR minimum of 16 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 for product registration, adverse event reporting, & recalls.

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

3. Extensive knowledge of international regulatory requirements, including Canada, China, Europe, Japan, Korea, Latin America, & United States.

4. Demonstrated experience interfacing with local & international regulatory bodies, such as US FDA, European competent authorities & notified bodies, Health Canada, China FDA, MFDS, MHLW/PMDA, etc.

5. Knowledge of Quality Management Systems

6. 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

7. Demonstrated project management skills to establish strategic goals and to prioritize, plan, delegate & evaluate deliverables

8. Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customers requirements.

9. Prior experience using spreadsheet and presentation software

10. Must be willing to travel up to 25% of time

**Desired Characteristics:**

1. Regulatory Affairs Certification (RAPS RAC).

2. Advanced degree in Regulatory Affairs, or a scientific, technology or legal discipline

3. Significant experience interfacing with external regulatory agencies (e.g. FDA) on pre-market and post-market issues, to detect trends and align priorities as needed

4. Demonstrated experience with a new product introduction process (i.e. new product launches)

5. Experience working across cultures/regions/sites

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

7. Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies

**About Us:**

GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GEs mission and deliver for our customers. www.ge.com

**Locations:** China; BeiJing; Beijing
Posted: 2018-12-06 Expires: 2019-01-06

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China Regulatory Affairs Leader

General Electric
Beijing, Beijing

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