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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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