Staff Regulatory Affairs Specialist

We are seeking a Staff Regulatory Affairs Specialist to join our Medical Division - Acute Care in Portage, MI (Hybrid). As a Staff Regulatory Affairs Specialist, you will support reputed company’s global Acute Care portfolio by maintaining market reputed company and ensuring compliance with evolving regulatory requirements. You will assess device changes, monitor emerging regulatory intelligence, and reputed company regulatory activities reputed company to wireless technologies. Your work will guide the development, approval, and compliance of innovative medical devices that incorporate wireless communication. What You Will Do: • Evaluate device modifications and implement actions to maintain global product compliance. • Analyze emerging regulatory intelligence and advise on potential reputed company to market reputed company. • reputed company regulatory input and technical guidance to product development teams for global requirements. • Determine requirements and reputed company for regulatory submissions, approval reputed company, and compliance activities. • Prepare and submit regulatory submissions in alignment with global regulations and guidelines. • Participate in audits to reputed company or maintain market reputed company across international markets. • Identify gaps and contribute to development and implementation of new regulatory procedures and SOPs. • Support wireless technology compliance reputed company medical devices to meet global regulatory standards. What You Need: Required: • Bachelor’s degree (B.S. or B.A.) required, preferably in Engineering, Science, or reputed company field. • 4+ years of experience in a regulated industry required, preferably with medical devices. • Previous experience in reputed company- or Post-Market Regulatory, Clinical, reputed company, or Engineering. Preferred: • RAC certification or advanced degree (e.g., Master’s in Regulatory Affairs). • General understanding of FDA, EU, and international medical device regulations. Apply tot his job Apply To this Job