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Senior Regulatory Affairs Specialist
4 months ago
Verathon, Inc.
Senior Regulatory Affairs Specialist
Bothell ,
Washington
Apply Now
Senior Regulatory Affairs Specialist - VerathonVerathon is seeking a highly experienced and motivated Senior Regulatory Affairs Specialist to join our dynamic QA/RA Team in Bothell, WA. As a key member of our team, you will play a crucial role in managing product approvals on a global scale. This is an exceptional opportunity for an individual who thrives in a fast-paced environment and possesses extensive regulatory knowledge.This is a hybrid role, working 3 days a week in the office (Monday, Tuesday, Thursday).Principal Responsibilities:Manage regulatory strategies for the worldwide device listing and registration of Verathon products in accordance with product development and business objectivesEnsure compliance with all applicable regulatory or clinical standards governing Verathon, Inc. productsPlan, develop, prepare, and obtain timely approval for product submissions to FDA and other worldwide regulators for Verathon\'s productsMentor an internal team of Regulatory associates, contracted clinical study, medical professionals or other consultants to achieve department and corporate objectivesManage the review and approval of product design, manufacturing and quality assurance changes and marketing advertising and promotional materialsEnsure compliance with internal procedures, applicable regulations and guidelines, local country registration requirements, and FDA\'s Quality System Design Control and labeling requirementsServe as key leadership team member in cross-functional program teamsProvide clear and consistent regulatory guidance to facilitate timely delivery of leading-edge products and services to Verathon customersKnowledge, Skills, and Abilities:Capable, confident individual contributor with 10+ years of experience and a BA or 8+ years of experience and a MS/MBAWorking knowledge of all FDA submission requirements; including 510(k), Q-Submission, IDE/IRB Clinical submissionsSubject Matter Expert in design dossiers and design history file content to ensure design documentation is adequate to support regulatory submissionsKnowledgeable and skilled core team regulatory affairs representative to ensure regulatory requirements are fulfilled and adequateMust be proficient in all areas of international regulatory requirements, including AU, NZ, China, Japan, EU, EE, and Middle East countriesOversee registration and distribution tools required to track and streamline world-wide regulatory approvalsWorking knowledge of both direct and distributor models needed to support international registrationsMust be familiar with distribution agreements, language requirements; and country specific MOH requirements for new product registrations and on-going renewalsMust possess excellent \"situational\" leadership skills with ability to work highly effectively in cross-functional teams and must thrive in a dynamic, fast-paced environmentMust have exceptional writing, verbal, and interpersonal skills with internal and external stakeholdersRequired to maintain positive, collaborative relationships with all regulatory agencies with whom Verathon\'s products are regulatedAssist with the growth and development of lower-level regulatory affairs professionals to sustain a productive and positive working environmentIf you\'re currently reading this and hesitating to click \"Apply\" because you don\'t check all the boxes, we encourage you to go for it A true passion and excitement for making an impact is just as important to us as work experience.Join Verathon and be part of our dedicated team as we continue to make a difference in the healthcare industry. We offer a supportive work environment that encourages professional growth and achievement. Apply today to take your regulatory affairs career to the next levelSalary range - \$112
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