In this role, you have the opportunity to
You will be a critical team member, regulatory SME, and strategist. You will plan, track and execute/write global regulatory submissions for global markets for new and sustaining product lines.
You are responsible for
Medical Device labeling expert, critical team member, regulatory subject matter expert, and partner for project teams.
Serves as labeling process owner from an RA perspective.
Plans, tracks and executes on global medical device labeling deliverables for new and sustaining product lines.
Requires mastery of medical device labeling symbols, UDI, and EU MDR labeling requirements.
Represents the Neuro BU (business unit) on internal Philips and external labeling-related committees.
Provides training to Neuro BU personnel on understanding, interpretation and implementation of labeling standards and regulations.
Liaise with Regulatory Affairs members and other cross-functional teams (e.g., supply chain, legal, clinical, R&D, Tech Comm, QA, etc.) to ensure the accuracy of all information included on the label or in the labeling.
Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.
Works on issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.
Implements strategic policies when selecting methods, techniques, and evaluation criteria for development and maintenance of medical devices.
Serves on national and international standards committees and industry organizations that establish or influence requirements on medical products/solutions.
Develops and revises QMS procedures and work instructions for medical device labeling.
Has regulatory experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
Assures adherence to budgets, schedules, work plans, and performance requirements.
Demonstrated ability to proactively manage product labeling needs for new product development and sustaining products.
Strong emphasis on exceeding customer expectations, while maximizing value to Philips and maintaining FDA/ISO and other regulatory compliance.
Thorough understanding of US, EU, and ROW labeling regulations.
Participate in project management meetings as the Regulatory representative.
Review and approve Change Orders for Regulatory compliance, including drawings and labeling changes.
Support preparation (markup/annotate and clean) packaging and labeling components.
Works with vendors/contractors to ensure adequate and timely support of project, compliance and proofreading activities.
Reports to Regulatory Affairs Director.
You are a part of
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces 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
Working knowledge of appropriate global medical device regulations, requirements, and standards
4+ years of experience in medical device product labeling
Bachelor’s degree required
Regulatory Affairs Certification (in the areas of US, EU, CA, and/or global regulatory affairs) desired
Has regulatory experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways
Ability to work independently and autonomously
Assures adherence to budgets, schedules, work plans, and performance requirements
Home based position, preferably on the West Coast
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?
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 the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
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.