Philips Regulatory Affairs Specialist in United States of America - Home Based, Massachusetts
null If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance. In this role, you have the opportunity to Formulate the medium term regulatory policy into a regulatory strategic plan, while also being involved in developing, modifying and executing company regulatory strategies and policies that affect immediate operations. You are responsible for
Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
Create detailed written regulatory plans that will be used to target domestic and international shipment dates.
Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations.
Review and approve advertising, promotional items and labeling for regulatory compliance.
Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
Communicate application progress to internal stakeholders
Collaborate with worldwide colleagues regarding license renewals and updates
Maintain regulatory files and tracking databases as required
Communicate with regulatory agencies as needed
Mentor other regulatory affairs personnel within GSC
To succeed in this role, you should have the following skills and experience
Bachelor’s degree or equivalent internationally-acquired qualifications preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry
5 + years of regulatory approvals and submittal experience (EU MDD, Health Canada, USA, etc.)
Must be able to manage multiple tasks and perform with accuracy and a high attention to detail
Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision
Proficient knowledge of domestic and international standards
Experience with FDA 510(k) submissions
RAPs RAC strongly preferred
Understand LEAN concepts, methodologies and deployment
May require 10% travel annually with possibly some international
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 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. Equal Employment and Opportunity Employer/Disabled/Veteran #LI-PH1 #LI-Remote
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