In this role, you have the opportunity to
Utilize your expertise and knowledge of regulatory requirements in developing Technical Documentation (Technical Files) compliant with the new EU MDR requirements.
You are a part of
You will have exposure to a multitude of indications, medical devices, and workflow solutions. This position partners with R&D, marketing, regulatory, quality, and legal among other functional areas where you will guide team members in application of all applicable regulatory requirements; ensuring documentation is adequate for successful regulatory submissions.
You are responsible for
Provide regulatory compliance guidance to drive global initiatives such as EU MDR.
Develop and maintain technical documentation (technical files) required for regulatory compliance to EU MDR.
Work closely with cross-functional teams including Research and Development, Manufacturing, Quality Assurance, Marketing and international geographies to develop a regulatory strategy for the business
Transparent sharing current, new and changing regulatory requirements, using your expert and proper interpretation to support medical device registrations in all global markets
Develop compliant regulatory submission packages which support successful approval or clearance to market
Work closely with other regulatory and clinical professionals to ensure all product and clinical information is adequately and correctly represented
Ensure Declarations of Conformity correctly represent all standards and regulatory requirements applicable to current technologies in the device
Identify issues that need resolution to ensure continued registrations in all global markets planned for commercialization
Participate in cross-functional meetings to provide regulatory perspective and interpretative knowledge
Knowledge of how to, or a willingness to learn to write protocols, reports, and other documentation to support international registrations
To succeed in this role, you should have the following skills and experience
An individual with a regulatory discipline as related to medical device products
5+ years of experience in international and US FDA 510(k) regulatory submissions
5+ years of experience writing and assembling technical documentation files or design dossiers
Deep knowledge about new EU MDR and differences to MDD
Experience in associated regulations relevant to labeling and use of international symbols
Knowledge of regulatory requirements for CE marking and UDI
RAPs RAC preferred
Ability to interpret applicable regulations to ensure compliance in a changing regulatory landscape
Ability to work nimbly, innovative approach to problem solving
Ability to work with international cultures
Strong organizational skills, ability to work on multiple projects, and work effectively in a demanding, time-sensitive environment
Interest in and passion for the medical device industry, bringing innovation to market
Effective working in multidisciplinary teams
Good communication skills, written and verbal
Proficient computer skills in Microsoft Office.
May require 5% travel annually with possibly some international
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa
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.