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Senior Specialist, Global Regulatory Systems at CooperCompanies

Jing'an District, Shanghai, China -

Full Time

Start Date

Immediate

Expiry Date

12 Oct, 26

Salary

0.0

Posted On

14 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, Technical Writing, Regulatory Affairs, Veeva Vault RIM, Change Management, Problem Solving, Analytical Skills, Medical Device Regulations, ISO 13485, ISO 14975, Electronic Document Management, Cross-functional Collaboration, English Fluency, Chinese Fluency, Microsoft Office Suite, Data Manipulation

Industry

Medical Equipment Manufacturing

Description

Representative for the Global Regulatory System team. The individual will be responsible for providing leadership, project management and training expertise to Regulatory Affairs team and cross-functional teams. Responsible for supporting the implementation, adoption and utilization of the systems required to allow Global and Regional Regulatory Affairs to fulfil their responsibilities. Liaises with multiple functions of the business, i.e., Regulatory, Global and Site Quality, Global Supply Chain, Global and Local Marketing, Legal, Site Operations, Clinical Affairs, Medical Affairs, R&D, and IT to assist with ensuring that information and documentation required by the regional teams in global product registration activities is available at the point of need. Provides guidance and training to Regulatory Affairs team members on the use of the systems in support of global and regional regulatory activities. Develops documentation, e.g. training materials / work instructions, to support the use of the regulatory systems. The Senior Specialist, Global Regulatory Systems operates against the RA Mission Statement: PROTECT the Business; GROW the Business. This involves engaging as a trusted and strategic business partner, delivering pragmatic solutions and creative regulatory strategies to: * PROTECT the business and our freedom to operate. * GROW the business and create real advantages for customers and wearers.

Responsibilities

Lead the implementation and utilization of global regulatory systems to support product registrations and regulatory activities. Coordinate with cross-functional teams to ensure necessary documentation is available and provide training and guidance on system use.