LinkedIn Group | Instagram | Facebook | Meetup | Sign in | Join_
Home                              

Global Regulatory Manager - Longgang District

Company Name & Description: 
DARCO manufactures and markets a variety of a variety of High Pressure Angiographic Syringes, tubing and accessories for power injector systems used in CT, MRI and Angio procedures. We are proud to provide quality medical products that save patients lives.

The Regulatory Affairs Manager is responsible leading and executing DARCO’s partner factory on global regulatory strategies, filing submissions and maintaining compliance with all US and international regulatory guidelines.

Duties & Responsibilities:

• Provide regulatory leadership and guidance to product development and quality departments to ensure successful global product registrations.
• Prepare for and file CMPA, FDA and CE product submissions, update existing product files; maintain establishment and product registrations
• Advise on international certifications and approving the filing
• Utilize knowledge and understanding of US, European and International Medical Device Regulations, Standards and Guidance Documents to manage compliance.
• Knowledge and good understanding of QSR and ISO Quality Management System Documentation.
• Participate in CNPA, FDA, CE, and ISO, customer and supplier audits
• Communicate with domestic and international business partners and direct interaction with regulatory agencies on product issues and questions.
• Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.

Candidate Requirements: 

• 8 plus years regulatory experience in the medical device industry commensurate with accountabilities described above.
• BA/BS degree in business, engineering, medical or scientific discipline.
• Extensive knowledge and understanding of US, European and International Medical Device Regulations, Standards and Guidance Documents.
• Knowledge and good understanding of QSR and ISO Quality Management System Documentation.
• Regulatory Affairs Certification (RAC) a plus
• Proven record of managing people/working on project teams while working on multiple projects.
• Ability to work with minimal supervision, recognize departmental and organizational needs and initiate actions/recommendations for resolution.
• Excellent Computer skills and written/oral communication
• Ability to meet deadlines and work under pressure
• Must speak, write and understand English fluently
• Knowledge of ISO 13485:2016, MDD 93/42/EEC, and 21 CFR Part 820

****PLEASE SEND YOUR CV WHEN YOU REPLY***

Education Level Required: 
College/university/polytechnic
Years work experience: 
8 years
Available For: 
Local Chinese
Salary Range: 
Not Specified
Position filled: 
No

Get two daily Shenzhen insider tips:

Login or Register to respond to this post

LoginRegister





info@shenzhenparty.com
call us: +86-755-3395-5850