Medical affairs • seattle wa
This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.Europe, support of international product registrations and related regula... Show more
Senior Regulatory Affairs Associate.Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infect... Show more
Director For Development, Global Affairs.The University of Washington has been a hub for learning, innovation, problem solving and community building for over 160 years.Supporting this legacy and i... Show more
Travel offering nursing profession medical assistant.Shift details shift 8 hour days.Job order details start date 06/08/2026 end date 09/07/2026 duration 13 weeks.Client details city Seattle state WA. Show more
Job Order Details: Start Date 08/03/2026 End Date 11/02/2026 Duration 13 Week(s).Client Details: City Seattle State WA. Show more
Advanced Cardiac Support Ma-C - Seattle, Wa.Temp To Hire Opportunity; This Position Is Available For Local Clinicians Only.Shift: 5x8hr Days, 0830-1700, Mon-Fri.Years Of Experience Req: At Least 6 ... Show more
Medical Assistant Electrophysiology.Schedule: Shift: 5x8hr Days, 08:3017:00, MonFri.Assignment Details: Contract Length: 13 weeks.Requirements: Minimum: At least 6 months experience as a Medical A... Show more
Director Of Public Affairs Programming.The KBCS Public Affairs Programming Director is responsible for overseeing independent reporting and producing original local and regional news and public aff... Show more
Accretive Technology Group — Government Affairs Analyst Location — This role is fully remote in the following states:.Arizona, California, Colorado, Florida, Michigan, Missouri, Nevada,... Show more
Exercise delegated managerial authority to oversee the overall planning, directing and timely execution of a program, several program segments (each of which is managed through separate subordinate... Show more
Quality Assurance And Regulatory Support Specialist.Serves as a subject-matter expert in quality assurance and regulatory support for clinical research at Seattle Children's Research Institute.Guid... Show more
Exercise delegated managerial authority to oversee the overall planning, directing and timely execution of a program, several program segments (each of which is managed through separate subordinate... Show more
Job Title: Medical Assistant - Medical Assistant<br /> Location (On-site, Remote, or Hybrid?): Seattle, WA (onsite)<br /> Contract Duration: 13 weeks<br /> Work Hours: 5x8hr Da... Show more
The Medical Assistant is responsible for a wide range of administrative and clinical tasks to assist our clinical providers.The Medical Assistant provides support in delivering excellent patient se... Show more
Labcorp is a leader in diagnostics, drug development and healthcare innovation.Across every role, we harness data and AI to work smarter, move faster and create breakthrough solutions that improve ... Show more
Boston; Remote; San Francisco; Seattle.Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune disea... Show more
Working at Planned Parenthood Great Northwest, Hawai'i, Alaska, Indiana, Kentucky is more than a job.It provides the opportunity to contribute to our powerful mission and perform meaningful work.In... Show more
Executive Director, Medical Affairs.Remote; Seattle, Washington, United States.Umoja Biopharma is an industry-leading biotech with locations in Seattle, WA and Louisville, CO, focused on transformi... Show more
This position is responsible for managing RPM’s global regulatory and product stewardship compliance program which includes the monitoring, tracking and timely communication of global regulatory de... Show more
Otolaryngology Medical Assistant.This position is for local candidates only as the clinic is interested in temp to hire.Must have a valid WA state license at time of submission.Schedule: 5x8hr, 073... Show more
The average salary range is between $ 106,250 and $ 245,250 year , with the average salary hovering around $ 171,000 year .
The average salary range is between $ 99,656 and $ 220,000 year , with the average salary hovering around $ 150,887 year .
This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analysis, problem solving, and attention to detail.
Represent RA on project teams by providing regulatory guidance throughout the product development cycle, coordinate team inputs for regulatory submissions, and review and approve applicable design control documentation.
Support International Product Registrations, including new registrations, re-registrations, and product change registrations/notifications.
Coordinate and collect specific registration information with R&D, Quality, Medical, Manufacturing, etc.
Assess necessity for submitting a 510(k) application for proposed device changes. Prepare internal "Non-Filing Justifications" (U.S.) for changes that do not require a 510(k) submission.
Prepare/update technical files for CE marking with appropriate input from various functions (R&D, Quality, Medical, Manufacturing, etc.).
Submit notifications to the EU Notified Body for significant changes to CE marked products.
Maintain Regulatory documentation.
Support special projects, as needed.
B.S. degree or higher in a life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistry.
2-5 years Medical Device experience.
Working knowledge of industry consensus standards and FDA guidance is required.
At least 2 years Regulatory Affairs experience in Medical Device regulations.
Demonstrated success in taking products through FDA and EU Notified Bodies.
Working knowledge of 510(k), MDD 93/42/EEC.
Regulatory Affairs Certified RAC (RAPS).
Proficient in using Microsoft Office.
Strong communication and project management skills.
Must be able to handle multiple tasks.
Attention to detail.
