Philips Senior Manager, Regulatory Labeling in San Diego, California
In this role, you have the opportunity to
The Senior Manager, Regulatory Labeling & Promotion will be responsible for development and implementation of global regulatory labeling strategies for all Philips Image Guided Therapy products. Through cross-functional collaboration, they will lead and provide tactical guidance to program teams, prepare Product Labels, with product specific Regulatory partners, as lead label negotiations with Health Authorities.
Additionally, this role will direct and conduct the regulatory affairs aspects of review and approval of medical and commercial material supporting external scientific communications for all products in the Philips Image Guided Therapy portfolio and pipeline. This is a leadership position within regulatory affairs and on product teams that requires comprehensive understanding of strategic global labeling and significant interactions with Commercial, Medical and Legal leading to product launch.
You are responsible for
Provide strong strategic guidance on Global labeling regulations, requirements, competitor labeling, and labeling trends
Participates in the product development team for early development product to provide labeling leadership in developing target labeling concept to guide the design and analysis plan for clinical trials.
Manages labeling negotiations with FDA and EMA; draft responses to Health Authority queries and revised labeling for submissions; track labeling-related Health Authority requests and responses
Prepares the submission ready labeling documents including the IFU and packaging artwork. Maintains and tracks labeling documents in the labeling repository and electronic system as appropriate.
Monitors the worldwide regulation and standard changes pertaining to Labeling requirements
Serve as an internal expert on global regulations (FDA, EMA, PMDA), guidance, and enforcement trends governing the promotion of medical devices and medical device and combination products.
Represent Regulatory Affairs during review of medical and commercial materials to support external scientific communications, ensure scientific and medical accuracy, adequacy of data and information supporting claims, and compliance with applicable laws and regulations.
Provide regulatory guidance according to the assessment of approved product labeling, references, applicable regulations and regulatory environment materials (i.e. enforcement actions, advisory comments, and guidance documents for the medical device industry, etc.)
Ensure compliance with applicable laws, regulations and Health Authority guidelines, as well as internal audit document requirements
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’s Degree required; advanced degree in health-related field (Pharm D, PhD, or equivalent) preferred
8+ years of medical device and/or biopharmaceutical and/or agency/medical education company experience
Demonstrated experience in leading the development and life-cycle management of global labeling.
Comprehensive knowledge of labeling regulations and guidance governing medical device development and maintenance in major markets (US, EU, Japan)
Proven ability to lead and influence others and to collaborate effectively with peers, global teams, and with senior leadership
Clear and effective verbal and written communication skills, and persuasive project management and presentation skills
Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships
Experience working on cross-functional teams and within a review committee
Ability to implement and manage multiple projects simultaneously, with high attention to detail
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.
This role offers you an opportunity to be a part a growing company and fantastic team passionate about developing novel medical device therapies to improve people’s live. You’ll have opportunities to learn and contribute creative solutions.
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 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.