Role Summary:
This position provides strategic regulatory direction to the business regarding regulatory
requirements for product launch, submissions and postmarket compliance. He / she leads a team
of regulatory professionals in preparing regulatory strategies, premarket submissions, postmarket
reporting, regulatory intelligence, regulatory requirements flow-down and postmarket compliance
(e.g. advertising / promotion, etc.), as applicable

Essential Responsibilities:

• Provides high quality, regulatory advice and is seen as a valued strategic partner to the business

he / she supports • Leads a team of regulatory professionals in a country, region or modality
(global) in execution of regulatory affairs tasks in support of the business • Ensures that regulatory
requirements for countries / regions are accurately captured and documented in global tools. •
Ensures the inclusion of applicable regulatory requirements in product development for target
countries • Prepares regulatory submissions by working across the regulatory organization and
cross functionally with other functions such as Engineering and submits premarket submissions to
regulatory authorities, as per business timelines • Prepares and files regulatory renewal /
extension applications to ensure continued market access, per business direction • Assesses
changes in existing products to and determines the need for new / revised licenses or
registrations. • Reviews and approves advertising and promotion material to ensure consistency
with approved claims and regulatory requirements. • Contributes to writing and editing technical
documents • Researches, analyzes, integrates and organizes background information from
diverse sources for regulatory submissions • Understands and applies regulatory requirements
and their impacts for submissions • Ensures compliance with pre- and post-market product
approval requirements • Supports regulatory inspections as required. • Assesses adverse events
and field actions for reportability to regulatory authorities and prepares and submits reportable
events and recalls in a timely manner to regulatory authorities, as per country regulations. •
Performs a broad variety of tasks in support of product and process design as assigned by the
departmental manager • Supports and encourages a collaborative, open and team based culture
across his / her organization and the larger Regulatory Affairs organization • Is an active member
of external industry trade associations and/or standards organization and/or other relevant
external groups to help shape regulatory requirements • Interacts with and represents GEHC in
interactions with regulatory agencies

Qualifications/Requirements:
Bachelor's Degree or a minimum of 10 years work experience.

• 5 years Regulatory Affairs / Quality Assurance experience
• A minimum of 5 years’ experience in the medical device or pharmaceutical industry
• Minimum of 1 year experience of regulatory project management and regulatory agency

interactions

• Experience of management of regulatory projects in global regulatory organizations
• Where required by law the Technical Responsible will meet required qualifications in terms of

education, certifications and experience (for example, Pharmacist in Brazil).

• Experience of working globally and across different cultures
• Ability to communicate effectively in English (both written and verbal).
• Demonstrated experience and proficiency with MS Office word processing, spreadsheet,

presentation and database applications

Desired Characteristics:
Minimum of 3 years supervisory/management experience is preferred • Advanced degree in
scientific, technology or regulatory affairs disciplines • Regulatory Affairs Certification (RAPS) •
Demonstrated understanding of healthcare environment and knowledge of current competitive,
commercial or political situations and their impact on GEHC regulatory strategies. • Third party
management and vendor selection experience • Strong team leadership skills, facilitates
teamwork, proven ability to lead and inspire • Assertive and willing to make decisions • Ability to
juggle and prioritize multiple competing priorities and complete tasks on-time • Ability to assign
clear priorities • Tenacious and delivery focused • Ability to make sound business judgments
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. • Complete all planned Quality & Compliance training within the defined deadlines.

• Identify and report any quality or compliance concerns and take immediate corrective action as

required.

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 GE’s mission and deliver for our customers. www.ge.com

Locations: China; BeiJing; Beijing