In this role, you have the opportunity to
Provide Regulatory Affairs Support for New Product Development and Sustaining efforts in both the domestic and international markets for Patient Interface Devices and other assigned medical devices. You will directly support registration and licensing in the US, Canada and EU and indirectly support the International Market groups for all other licensing. You will work as a Regulatory Affairs Engineer on problems of diverse scope where analysis of regulatory data requires evaluation of identifiable factors. The development of the solution requires a multi-disciplinary approach and knowledge of regulatory principles, theories and concepts.
You are responsible for
Working independently on the Regulatory duties, processes and roles outlined below:
Supports and provides regulatory expertise to assigned medical device new product development and sustaining projects from initial kick-off to post-marketing phase
Creates and executes complex Regulatory Strategies and Plans for assigned medical devices in the US and international markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers.
Develops the standards strategy for medical devices and supports activities required to maintain regulatory compliance as new or revised versions of standards are released.
Prepares and submits US FDA pre-sub, 510(k) and other product submissions and prepares internal regulatory evaluations according to FDA guidelines.
Creates and updates European Technical File and Declaration of Conformity documents (MDD, MDR, RED, RoHS, etc.) and Canadian licensing submissions according to international guidelines
Maintains expertise in domestic and international regulations and standards, with a focus on assigned medical devices and regional focus on the US, EU, and Canada.
Supports the international regulatory team, as needed, with inputs into the registration packages they prepare and to address questions received from government agencies.
Reviews and approves product labeling plans, labeling, and marketing communications.
Supports regulatory activities in internal and external quality audits, as needed.
At Philips we are passionate about improving quality of life with solutions designed around the needs of customers and their patients. Innovation is driven by gaining insight to the needs of the people who use our sleep and respiratory solutions. This tradition of innovation, combined with our ability to anticipate market needs, has made Philips a global leader in the markets we serve.
Here at Philips WE ARE Working Together for a Better Tomorrow
Philips' dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.
Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.
Thanks to our employees, we are at the forefront of the Healthcare industry. Healthcare providers, backed by our many market leading solutions, are able to diagnose confidently, improve care, and increase the quality of life for patients across North America each and every day.
To succeed in this role, you should have the following skills and experience
Bachelor’s degree with 5+ years of related experience in regulatory affairs engineering; or a Master’s degree with 3+ years of related experience in regulatory affairs engineering. RAC preferred. Unique combinations of education and experience may be substituted if they provide the essential skill sets for the position.
The successful candidate will have:
Knowledge in the area of FDA procedures and practices, a working knowledge of medical device regulations, and experience in the medical device industry. Has basic knowledge of related disciplines.
Ability to carry out successful interactions and negotiations – experience with FDA premarket notification submittals and experience interacting with FDA.
Knowledge in the area of the Quality System Regulation, the EU Medical Devices Directive and/or Medical Device Regulations, Canadian Medical Device Regulations and other national and international regulations.
Ability to formulate the solution for (technical) partial problems that cannot be found by combining previous experiences but by composing newly acquired regulatory knowledge. Ability to apply advanced regulatory process principals to multiple tasks and introduce regulatory methods/procedures that are new for the organization.
Works independently, and may lead multi-disciplinary regulatory change projects, managing a number of team members’ support of the project.
Excellent technical writing and verbal communication skills.
Ready to start improving lives by putting your personal skills & passions to work? Apply Today! Not yet ready to apply? That’s okay! Learn more about us by joining our Talent Network on LinkedIn or following us on Twitter at @PhilipsJobsNA .
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.