Johnson & Johnson Careers

Regulatory Affairs Manager

Beijing, China
Regulatory Affairs


Job Description

Requisition ID: 1805646082W

Principal Duties and Responsibilities (General Summary ,essential functions and authorities, etc.)
主要工作职责(基本概况,主要功能,权限等)

Adherence to J&J credo and industrial code of conduct ethics, good regulatory practice and global regulatory policies.
Post market surveillance:
- Following the current company QMS SOPs and RA SOP to support PMS handling.
- Coordinating company External Affairs Council to SOPs efficiency implementation.
- Conducting communication with relevant business units and regulatory business groups for post market surveillance issues handling to the SOPs’ implementation and timely update.
- Working the alignment with sourcing company on PMS issues.
- Leading the communication with CFDA and collaborating local PMS team’s communication with local FDA.
- Delivering the regulatory explanation of regulations to internal and external stakeholders.
Timely provide regulatory support and PMS expertise (involvement in internal audit) when required to other departments if needed.
Fulfil other tasks assigned.


Qualifications
任职资格
At least master degree on medical or pharmaceutical or related subjects。
At least 3-5 years working experience and 1-3 years’ leadership experience in regulatory compliance or other related areas in medical device or pharmaceutical industries.
Fruitful knowledge and experience in compliance and legal profession in healthcare industry
Good leadership and communication skill.
English fluent in reading, writing, oral and listening.
Good project management and time management skills.
Familiar with routine operations of computer and software.

Primary Location
China-Beijing-Beijing
Organization
Johnson & Johnson Medical Shanghai Ltd. (7055)
Job Function
Regulatory Affairs
Requisition ID
1805646082W