In this role, you have the opportunity to
Team up with business unit Regulatory Affairs Specialists and international regulatory staffs to provide regulatory support for new product development and changes to existing products. You’ll work with Regulatory and Quality staff, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
Provide Regulatory support for Image Guided Therapy’s new product development. You’ll provide assessments of all post market changes to commercialized products and be a critical function to enable Market Compliance of product supply.
You are responsible for
Prepare FDA submissions and CE Mark Technical Documentation Files for product changes and/or new products as required to ensure timely approvals for market released products.
Provide support to currently-marketed products as necessary. This includes reviewing product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status. May interact directly with FDA and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.
Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
Follow all work/quality procedures to ensure quality system compliance and high-quality work.
Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy
Compile materials for license renewals, updates and registrations in a timely fashion.
Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners
Review labeling and labels for compliance with regulatory requirements
Review changes to existing products and SOPs to define the requirements for regulatory submissions
Provide the regulatory reviews of product quality issues and define the approach for applicable regulatory communication
Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products
Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes
Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required.
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.
BS degree in relevant field. (BS, MS, or PhD in Engineering or Science preferred.)
7+ years of medical device experience with BS degree and work experience in Regulatory Affairs,
Excellent communication both written and verbal as well as have experience with communication and presentations to senior leadership.
Demonstrated experience in multiple types of substantive regulatory filings such as PMAs, 510ks, EU Technical Documentation Files, Japanese Shonin, or Canadian Regulatory Submissions.
Must have working knowledge of FDA, ISO, EU, and other applicable regional regulations for handling complaints, reporting incidents, and implementing corrective and preventative actions.
Ability to makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines.
Knowledge of PC hardware/software, documentation and archives
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. 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 on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
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.
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.
Equal Employment and Opportunity Employer/Disabled/Veteran