法规事务工程师（m / f / d）中国项目

niweiditerui

Regulatory Affairs Engineer (m/f/d) China Projects

Job Description
In this role, you have the opportunity to Provide regulatory leadership for Patient Monitoring product lines and is responsible to build and deliver on competitive regulatory strategies in China. You work directly with Philips regulatory counterparts in China to support and achieve best possible outcomes for effective product market clearances.

You are responsible for  
The coordination and preparation of document packages and the project management for regulatory submission projects in Chin
Provide Regulatory Technical Competency (tactical and strategic) to the Patient Monitoring Business Unit (BU) with a particular focus on Chin
Participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements, and standards (not in the field) in order to support Marketing roadmaps for Greater China
Review development quality reports and plans to ensure that the information required for Chinese submissions is adequate
Plan, generate, and coordinate regulatory submissions for product/solution licensing
Coordinate testing required to support regulatory submissions
Review and approve product/solution labeling and product/solution-related marketing communications
Maintain existing regulatory filings/ licenses, managing updates and related change control processes  for Greater China
Primary regulatory liaison between BU and China regulatory team.
Lead submission projects showing project management skills with BU and Greater China Regulatory Affairs team
Advises product design teams on regulatory strategy and requirements for specific new products/solutions
Responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance
Supports development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, and product registrations such as CE Marking and clinical evaluations. Develops and facilitates regulatory submissions, for new products/solutions, existing products/solutions
Reviews and validates marketing and labeling materials

You are part of Monitoring/Analytics & Therapeutic Care (MA &TC) designs, and develops best-in-class monitoring solutions, telemetry, clinical measurements, and clinical decision support systems  that simplify clinician workflow, improve financial outcomes and help improve and save lives.
The Quality & Regulatory department supports patient care and clinical Informatics products and solutions with focus on patient monitoring. We ensure worldwide product approval and compliance with all applicable Regulations and requirement.

To succeed in this role, you should have the following skills and experience
Engineering degree (Bachelor or Master)
3+ years experience in Quality & Regulatory Affairs including Regulatory approval experience
Demonstrated project management skills
Familiar with International Regulations, Standards and QS requirements
Good interpersonal skills and strong communication skills, team player  
Experience within a process oriented working environment
High reliability and quality focus
Fluent in English and Mandarin; German on top is preferred
Preferred:
Medical Product knowledge
Demonstrated project management skills

In return, we offer you
Working in the medical industry brings much fulfillment, as well as unique opportunities to grow. By taking pride in all you do and inspiring others around you to prioritize Quality above all else, you’ll be contributing to a higher Quality of life for billions and helping Philips deliver innovation that matters.
We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.

Philips encourages people with a disability to apply.

https://www.careers.philips.com/ ... -f-d-China-Projects