Job
Description
We at Phoenix Medical Systems Pvt. Ltd., based in Chennai and established in 1987, are committed to enhancing maternal and neonatal care by developing high-quality, affordable medical equipment. Our range includes infant warmers, incubators, phototherapy units, CPAP systems, and delivery beds. With a presence in over 60 countries, we serve hospitals and healthcare providers worldwide with reliable and innovative solutions. JOB OVERVIEWWe are seeking a Regulatory Specialist with a strong background in medical device regulatory submissions, particularly for US FDA (510(k)), EU MDR, and IMDR. The ideal candidate will have hands-on experience in compiling technical documentation, understanding global regulatory frameworks, and supporting cross-functional teams to ensure timely and compliant submissions. Key Responsibilities: To Prepare the technical dossier and ensure all technical and regulatory documents are accurately completed and submitted in a timely manner for 510(k) US FDA , European CE ( EU MDR) and CDSCO SubmissionTo Collaborate with cross-functional teams (R&D, Quality, Marketing) to define regulatory strategies and ensure alignment with regulatory requirements.To ensure products and submissions comply with FDA regulations, standards (e.g., 21 CFR 820), and guidance documents and EU MDR regulations. To address regulatory questions and manage any follow-up communications related to submissions. To monitor and track submission timelines and follow up on the status of pending approvals. Ensure timely responses to requests for additional information from the FDA.Continuously monitor changes to national/international/regulatory standards, guidance documents, and industry standards to ensure all submissions are in compliance with current regulatory requirements.To review product labeling, technical files, risk assessments, and other documentation for regulatory compliance.To Provide guidance and regulatory support to various departments, including Quality Assurance, Engineering, and Marketing.Maintain up-to-date, well-organized records of regulatory submissions and all related documentation, ensuring easy access for audits or reviews. Requirements:Education: Bachelor's / Master degree in Biomedical Engineering, Bio-Medical Instrumentation, or a related field.Experience: 2–3 years of relevant experience with direct involvement in 510(k) and EU MDR technical documentation.Knowledge:Strong understanding of ISO 13485, FDA 21 CFR 820, EU MDR, and IMDR regulations.Familiar with GSPR, risk management (ISO 14971), and clinical evaluation.Technical Skills: Experience using document management systems and regulatory submission tools.Communication: Excellent written and verbal communication skills.Problem-Solving: Ability to manage complex regulatory challenges independently.Teamwork: Proven ability to work cross-functionally with minimal supervision. Preferred Qualifications:Certification in ISO 13485, EU MDR and 510 (K) Experience with other geographical regulatory submissions Familiarity with international regulatory requirements
