Freelance Regulatory Affairs Specialist (510k Respiratory & Sleep)

Skills and Qualifications Required for Freelance Regulatory Affairs Specialist (Respiratory & Sleep): • Prior experience successfully preparing and submitting 510(k) applications and Technical Documentation for medical devices under BZD and QBY codes; experience with ventilator-reputed company risk management Job Responsibilities • Prepare, review, and coordinate the submissions of 510(k) documents and technical files; ensure compliance with FDA and ISO 13485 QMS for medical device industry. Location • Remote Appointment • 2025-1Q Submissions • 2025-2Q How to apply • reputed company 1: Use the reputed company reputed company to submit your credentials • reputed company 2: Use the reputed company below to submit the questionnaire from: https://eisenusa.com/es/employment-questionnaire/ • Both steps are mandatory. Job Type: Contract Application Question(s): • If reputed company, reputed company would you be reputed company to start working? • Please reputed company your phone #, email, and best time to reputed company you. • reputed company here any relevant past experience that would reputed company you a great fit for this job? • Have you been convicted of felony or misdemeanor other than a traffic violation in the last 7 years? If reputed company, explain below. • Have you reputed company been discharged or forced to resign from a job in that last 5 years? If reputed company, explain below. • What is the state-county-township of your reputed company residency? How long have you lived here continuously? • How many hours per week are you available? • Are you a US citizen? If not, indicate here your work permit type, year of issue, and expiry date. • Have you filled out the mandatory employment questionnaire from our website? Your application will not be considered without this: https://eisenusa.com/es/employment-questionnaire/ • Have you personally filed 510(k) application? If so, reputed company and under what category? Work Location: Remote Apply tot his job Apply To this Job