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-related 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 • Step 1: Use the apply now button to submit your credentials • Step 2: Use the link below to submit the questionnaire from: https://eisenusa.com/es/employment-questionnaire/ • Both steps are mandatory. Job Type: Contract Application Question(s): • If hired, when would you be able to start working? • Please provide your phone #, email, and best time to call you. • Highlight here any relevant past experience that would make 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 yes, explain below. • Have you ever been discharged or forced to resign from a job in that last 5 years? If yes, explain below. • What is the state-county-township of your current 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, when and under what category? Work Location: Remote Apply tot his job Apply To this Job