Philips Principle Regulatory Affairs Specialist in San Diego, California
As the incumbent of this Regulatory role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval requirements and regulatory compliance in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
About the Image Guided Therapy (IGT) Devices group within Philips Healthcare
We are revolutionizing the medical device industry with a broad suite of technologies that make imaging and therapy simpler, more informative and less invasive. Our products empower physicians around the world with a new generation of analytical tools that deliver more meaningful information - using sound and light as the guiding elements. Founded in cardiovascular care and expanding into other specialties, Philips Volcano is changing the assumption about what is possible by combining imaging and therapy together.
About the Position Our Principal Regulatory Affairs Specialist will provide regulatory support to the Regulatory Affairs Department ensuring compliance with applicable US and international regulations in which the company does business; providing Regulatory guidance to new product development teams, preparing product submission documentation, interacting with Regulatory Authorities, evaluating product changes for effects on regulatory license registrations, and ensuring compliance to company policies and procedures.
Participate in new product development teams providing regulatory strategy
Assist in the integration of newly acquired businesses or products
Review and approve new product development documents, including but not limited to test protocols and reports, risk analysis documents, clinical protocols
Prepare and maintain regulatory submissions, including 510(k), PMA, LTF, IDE, Technical Files / Design Dossier, and International Registration documentation as required
Review and approve Marketing Promotional Materials
Participate in compliance projects to ensure ongoing compliance to standards and regulations
Maintain current knowledge on global regulations
Other responsibilities as assigned.
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.
Location : San Diego, CA
We are looking for:
A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience, challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life for the billions of people the Philips brand touches each year.
Specific skill requirements for this role include
BA/BS in a scientific discipline or equivalent work experience
Regulatory Affairs Certified (RAC) preferred
A minimum of five (5) years of experience in Regulatory Affairs or Regulatory Affairs /Quality Assurance field combined.
Demonstrated knowledge of FDA and international regulations
Demonstrated successful submission in US, EU, Japan, and international regions
Ability to work independently and within a team environment
Well-developed organizational skills required
Effective written and verbal communication skills
Previous practical experience in regulatory activities in cardiovascular medical device applications highly desirable
Ability to work collaboratively
Detail oriented and thorough
Good analytical/problem solving skills
Ability to work independently and have good time management skills
Proficiency in Microsoft Office Suite, particularly Word and Excel
US and international travel as required for seminars, training, and conferences
This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
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.