Sr. Regulatory Affairs Specialist - Medical Device - Job ID: 245129

Sr. Regulatory Affairs Specialist - Medical Device - Job ID: 245129 Sr. Regulatory Affairs Specialist - Medical Device - Job ID: 245129 This range is provided by Medix. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $100,000.00/yr - $130,000.00/yr Additional compensation types Annual Bonus Direct message the job poster from Medix Recruiting Partner to Life Science and Engineering EnthusiastsWannabe Cat Whisperer, Good Food Geek, Girls on the Run Coach Medix is hiring for a Sr. Regulatory Affairs Specialist to join our client's team. In this direct hire role, you'll be instrumental in ensuring our medical device products meet all global regulatory requirements. You'll work closely with various teams to guide products from development through commercialization and post-market activities, ensuring timely submissions and compliance. If you're a strategic thinker with a strong regulatory background in the medical device field, we want to hear from you. What You'll Do Prepare and submit a variety of domestic regulatory documents, including U.S. FDA 510(k)s. Manage the creation and maintenance of Technical Files and other required regulatory documentation. Lead the development of regulatory strategies for new products and assess the regulatory implications of design changes. Provide essential regulatory support to project teams and other departments, ensuring a compliant approach throughout the product lifecycle. Oversee the preparation and review of product labeling. Coordinate correction and removal (recall) activities , including drafting and submitting required reports. Provide regulatory support for key quality system processes such as ECOs, MCOs, and NCMRs. Lead health hazard evaluations to address post-market product issues. Participate in external inspections by regulatory bodies (e.g., FDA). Drive process improvements to enhance regulatory compliance and efficiency. What You'll Need A college degree or equivalent experience in Regulatory, Quality, or R&D. A minimum of 4 years of experience in Regulatory Affairs , with a significant portion in the medical device industry. Proven experience leading design control activities and providing regulatory expertise for product development. Strong experience with U.S. product registration, including 510(k) writing experience . Knowledge of FDA QSR requirements and ISO 13485. Excellent oral and written communication skills with the ability to lead meetings and present information effectively. A proactive attitude with the confidence to provide and defend regulatory guidance to cross-functional teams. Exceptional attention to detail and strong organizational skills to manage multiple projects and deadlines. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Legal, Strategy/Planning, and Science Industries Medical Equipment Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at Medix by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Get notified when a new job is posted. Sign in to set job alerts for “Regulatory Affairs Specialist” roles. Carlsbad, CA $90,000.00-$100,000.00 5 days ago Carlsbad, CA $97,000.00-$128,500.00 6 days ago Manager, Vendor Contracts & Regulatory Affairs Global Product Development Quality Specialist RN - Regulatory and Accreditation- Part Time -Vista We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr Medix™