Regulatory Affairs Manager
Philips
In this role, you will lead the Business Regulatory Affairs for our MRI Business Unit in China and be accountable for developing and deploying innovative, compliant regulatory strategies to grow and sustain the Philips portfolio, which drives Philips’ mission to improve the lives of 2.5 billion people by 2030. Key opportunities exist to build and strengthen regulatory capabilities, build relationships with regulators, and drive compliant NMPA regulatory strategies and submissions.
**Your role:**
+ Leading MR Regulatory Affairs team of MRI Business Unit in China from end to end (Regulatory Strategies and Submission) value-added regulatory affairs input and deliverables for new product introductions and product changes in China.
+ Leading the development and deployment of innovative Regulatory strategies to efficiently and compliantly bring products to the market and maintain them compliantly to support business growth.
+ Leading strategy and execution of functional excellence to improve the performance of the regulatory function and ultimately bring increased value to the MR Business Unit
+ Providing interpretation of NMPA regulations and Standards to MR Business Unit for early adoption of the requirements into our Innovations.
+ Providing critical input on regulatory risk assessments to support portfolio selection
+ Building proactive, robust, strategic relationships with external stakeholders (NMPA, Notified Bodies, State Authorities, and Industry Associations) to influence and shape the external regulatory landscape across the domains relevant to the partnership agenda
+ Leading and enabling strong cross-function partnerships between Regulatory Affairs and all key stakeholders, including R&D, Marketing, Quality, Clinical Affairs, and other functions within the Business Unit.
+ Responsible for the hiring and developing of critical talent within the Global Regulatory Affairs Team through creating and sustaining robust career & development plans, ongoing coaching and feedback, and identifying and addressing gaps in capabilities and competencies.
**You're the right fit if you have the following:**
+ Bachelor's degree, preferably in an engineering or life-scientific field
+ A minimum of 8-10 years of experience working in Regulatory Affairs within the Medical Device industry (Experience with SaMD, AI, and/or digital health is a significant advantage)
+ Extensive experience and knowledge required of global medical device regulations, requirements, and standards
+ 10 years of experience in people management – with a strong track record in successfully leading a Regulatory Affairs team
+ Proven track record of leading in a matrix organization, leading cross-functional and diverse teams with challenging goals
+ Experienced in strategic relationships with external stakeholders (Competent Authorities, Industry Associations)
+ Experience with successfully leading, preparing, and submitting Design Dossiers, 510(k), NMPA Submission,Technical /Design Dossiers, and international documents or medical device registration worldwide.
**How we work together**
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office/field/onsite role.
**About Philips**
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
* Learn more about our business.
* Discover our rich and exciting history.
* Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
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