北京招聘

Business Segment

Healthcare Quality

Role Summary/Purpose

The Regulatory Affairs Leader provides subject matter expertise and works with a team of regulatory affairs professionals to ensure GEHC establishes best practice within the assigned area of responsibility (regional regulatory submissions & reporting, technical standards, collection and dissemination of intelligence, influencing the global regulatory environment, etc).

Essential Responsibilities

ey responsibilities include:
• Work closely with regulatory, engineering, marketing, legal, and other professionals across the company to develop & implement company-wide programs and processes for regulatory affairs compliance within areas of responsibility.
• Identify regulatory trends and their implications for GE Healthcare; Develop & implement effective regulatory strategies to meet business objectives
• Analyze & communicate proposed, new or changing requirements, & devise strategies for their implementation, ensuring business goals are met.
• Scan the external environment and work with external associations to proactively adapt regulatory strategies and influence change within areas of responsibility.
• Educate, train, & advise company professionals to ensure compliance with RA requirements.
• Audit business units for compliance and consistency, and track/address trends observed that could lead to non-compliance, or risk to patient/user safety.
• Collect, summarize & evaluate performance metrics to identify program weaknesses & drive improvements in procedures or oversight.
• Support continuous improvement activities with regard to areas of responsibility.
• Drive improvements to overall Quality Management System documentation to provide clear flow down of regulations in areas of responsibility.

Qualifications/Requirements

1. Bachelor’s Degree & minimum of 5 years experience in the medical device or pharmaceutical industry or government / government relations; OR minimum of 10 years progressive regulatory affairs experience in medical device or pharmaceutical industry or government / government relations, including knowledge & experience applying global drug or device laws & regulations for product registration, adverse event reporting, & recalls.
2. Ability to prioritize, plan & evaluate deliverables to established strategic goals.
3. Demonstrated experience operating in a highly regulated environment; Proven application of analytical skills in a regulatory environment
4. Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research.
5. Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner
6. Prior experience using spreadsheet and presentation software
7. 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. Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL.
4. Knowledge of Quality Management Systems (QMS)
5. Ability to work across cultures/countries/sites
6. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
7. Strong problem solving and negotiation skills
8. Ability to work well independently & in a team setting.
9. Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies.

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