Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.

　　In this role you have the opportunity to

　　Provide Regulatory Affairs Support for Advanced Innovation New Product Development and Sustaining efforts in both the domestic and international markets for assigned medical devices and consumer products. Provide direct project support for registration and licensing in the US, Canada and EU and indirect support to 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.

　　Your role:

　　Working independently on the Regulatory duties, processes and roles outlined below:

　　Supports and provides regulatory expertise to assigned medical devices and consumer product development projects from initial kickoff to post marketing phase.

　　Creation and execution of complex Regulatory Strategies and Plans for assigned medical devices and consumer products in the domestic 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 according to FDA guidelines.

　　Creates EU Technical File and Declaration of Conformity documents (MDD, RED, LVD, 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 (FDA), EU (MDD), and CA (Health Canada).

　　Support the international regulatory specialist team with inputs, as needed, into the registration packages they prepare.

　　You're the right fit if:

　　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.

　　3 years of experience in the medical device industry

　　Must have experience with successful preparation and submission of 510(k), PMA, or international documents or registration, labelling and marketing of medical device worldwide

　　Experience in Design Controls

　　Working knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations.

　　Experience in supporting international registrations and clinical investigations

　　US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

　　About Philips

　　We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

　　Learn more about our business (https://www.philips.com/a-w/about.html) .

　　Discover our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)

　　Learn more about our purpose. (https://www.philips.com/a-w/about/environmental-social-governance/our-purpose)

　　Read more about our employee benefits (https://www.careers.philips.com/na/en/best-employee-benefits) .

　　If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here (https://www.careers.philips.com/global/en/diversity-and-inclusion) .

　　Philips Transparency Details

　　The pay range for this position is $74,000 to $136,000, annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

　　In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here (https://www.careers.philips.com/na/en/best-employee-benefits) .

　　At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

　　Additional Information

　　US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

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　　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.

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