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Posted: Saturday, May 13, 2017 3:34 AM

Your Challenge As a core member on product development teams, the Regulatory Specialist will provide timely and valued regulatory guidance.. Your Responsibilities: 1. 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. 2. Create detailed written regulatory plans that can be used to target domestic and international shipment dates. 3. Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations. 4. Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance. 5. Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project. 6. Provide significant regulatory support to ongoing PMA activities. Additionally, the Regulatory Specialist will: · 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 ECR Your Profile · Bachelor’s degree (Master’s preferred) preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry. · RAPs RAC strongly preferred. ASQ certifications also desirable. · Minimum of 5 years of experience in the medical device industry (EU MDD, Health Canada, US FDA class II and class III, etc.). · Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations and standards. · Must have personal experience with successful preparation and submission of 510(k) and PMA submissions. · 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 · Strong background in Design Controls. · Experience in supporting international registrations and/or clinical investigations. · Must be able to manage multiple tasks and perform with accuracy and a high attention to detail · Proficient computer skills in Microsoft Office. · Understand LEAN concepts, methodologies and deployment. · May require 5% travel annually with possibly some international. Our Offer 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. Advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first. Find out more info about Philips at www.philips.com/na/careers Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status. #LI-AH1

Click here for more info: https://philips.taleo.net/careersection/jobdetail.ftl?job=188294&lang=en


• Location: Seattle

• Post ID: 45704613 seattle
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