Principal Regulatory Affairs Specialist
Source: beBee S2
If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request.Â You may contact 888-367-7223, option 5, for assistance.
In this role, you have the opportunity to
Shape, lead and execute innovative regulatory strategies to drive innovation within the Philips Innovation and Strategy organization globally. Work closely with various stakeholders from global Philips Innovation Hubs, and regulatory leaders from different clusters, to enable and accelerate regulatory approvals for innovative solutions in all target markets.
You are responsible for
- Plan, generate, and lead global regulatory strategy for Artificial Intelligence within Innovation & Strategy and CTO and ensure consistent approach across all clusters;
- Provide regulatory subject matter expertise, guidance and support to all critical advanced development activities within the Philips Research organization;
- Able to identify risks within regulatory strategies, project plan, and outline proposal for balancing the project risks to projects and the regulatory management team;
- Lead regulatory submission activities, and directly interact and negotiate with pertinent regulatory authorities on regulatory filings to achieve on time approvals;
- Driving improvement in regulatory aspects of the Quality Management System and in developing processes and documenting procedures to ensure an effective Quality System is maintained;
- Provide guidance on global compliance, such as CE Marking and product registrations, China NMPA, Canadian CMDCAS, Japan PMDA, compliance with FDA's guidance documents, and including requirements that are relevant to the overall Philips Innovation & Strategy priorities globally;
- Ensuring compliance with the current regulatory procedures and where needed, generate new and/or update procedures when new regulatory requirements are determined to go into effect;
- Providing regulatory support for (pre-) clinical studies, including recommending strategies to optimize clinical study approvals and review of clinical study protocols;
- Where applicable, represent Philips in an international committee chartered to develop AI regulatory framework;
You are a part of
As a result of Philips renewed dedication to Quality, it has recently restructured its organization to ensure you and your department have clear collaboration with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
To succeed in this role, you should have the following skills and experience
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
- Bachelor/Master of Science degree in a technical discipline;
- Minimum of 6 years of experience in MedTech industry shaping, leading and executing regulatory strategies for software enabled medical devices, including AI and digital health solutions;
- Extensive experience with Software or Software as Medical Devices
- Experiences in regulatory strategies surrounding AI/ML enabled Medical Devices, is preferred;
- First line experience with US FDA, China NMPA and EU MDD/MDR is required;
- Experiences surrounding international regulatory submissions and registrations is required;
- Must have experience with successful preparation and submission of Technical Documentation, US 510(k), De Novo, PMA, and registrations of medical devices globally;
In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global 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. Furthermore, Philips University is available to all employees for learning and development opportunities.
Why should you join Philips?Â
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across theÂ health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.Â Â
To find out more about what it's like working for Philips at a personal level, visit theÂ Working at Philips pageÂ on our career website, where you can read stories fromÂ ourÂ employee blog. Once there, you can also learn aboutÂ ourÂ recruitment process, or find answers to some of theÂ frequently asked questions.Â
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person's relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.Â
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Â
Equal Employment and Opportunity Employer/Disabled/VeteranÂ
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