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 OVERVIEW

We 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 Submission
• To 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:

1. Strong understanding of ISO 13485, FDA 21 CFR 820, EU MDR, and IMDR regulations.
2. 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