Regulatory Assistant Manager
In this role, you have the opportunity to
- Coordinate, review, and file new device registration/approvals and amendments to existing products for market access into the Peoples Republic of China. Communicates with relevant competent authorities, agents, distributors and local sales offices to ensure the most efficient path to application approval.
- Advise local and international teams on the most expedient route to obtaining product licenses, and ensure market access strategy is aligned with local and international marketing/sales requirements.
- To resolve any conflicts of strategy with marketing/sales strategies and determine the regulatory impact of such strategy on license approval timescales.
You are responsible for
- Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc.
- Create detailed written regulatory plans that can be used to target domestic and international shipment dates.
- Develop and take the ownership of China CFDA submissions
- Support Key market RA team on global registrations
- Establish active communications with regulatory agencies in China.
- Review and approve advertising, promotional items and labeling for regulatory compliance
- Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
- Communicate application progress to internal stakeholders
- Collaborate with worldwide colleagues regarding license renewals and updates
- Maintain regulatory files and tracking databases as required
- Other things assigned by your manager
You are a part of
Great china Q&R&MA team
To succeed in this role, you should have the following skills and experience
- BS in engineering discipline or equivalent education, experience, training.
- At least 4 years regulatory experience in medical device industry.
- Experience in China local manufactured or local developed products will be a plus.
- Strong understanding of NMPA and other major international regulations
- Be able to manage multiple tasks and perform with accuracy and a high attention to detail
- Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.
- Proficient in English communication including reading, writing, speaking and listening.
In return, we offer you
- A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. 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.
- A professional but fun workplace, A healthy work-life balance environment;
- An energetic, genuine, inventive, supportive and dynamic team atmosphere;
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Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven.
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