Manager- Medical Device

Job Description: Manager Medical Devices

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Job Description

Manager- Medical Devices

Regulatory Affairs

Prepare, compile and manage regulatory submissions, including FDA 510(k), CDSCO registration, CE Marking (EU MDR), SFDA, and UKCA.

• Develop and maintain technical files, dossiers, registration documentation, and regulatory reports in accordance with applicable requirements.
• Coordinate responses to regulatory queries, address deficiencies, and manage follow-up communications with regulatory authorities.
• Conduct regulatory gap assessments and ensure ongoing compliance with current and evolving regulatory requirements.

Quality Management System (QMS)

• Implement and maintain and continuously improve the Quality Management System (QMS) in compliance with ISO 13485 and applicable national and international standards.
• Plan and conduct internal audits, and support external audits by regulatory bodies and certification agencies.
• Coordinate and support certification activities for ISO 13485, ISO 11135, ISO 11137, ISO 11737, and ISO 14971.
• Review SOPs and other quality system documentation to ensure adequacy, compliance, and effective implementation.

Design, Development & Risk Management

• Review design and development documentation Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR).
• Lead risk management activities in accordance with ISO 14971 and related regulatory requirements.
• Support process validation, equipment qualification/validation, and sterilization validation activities.

Customer Support & Post-Market Surveillance (PMS)

• Handle customer complaints, technical issues, and field reports in accordance with the established procedures.
• Manage PMS activities, including data collection, trend analysis, and initiation and follow-up of CAPA.
• Manage adverse event investigations, vigilance reporting, and timely regulatory notifications to the applicable authorities.

Cross-Functional Collaboration

• Coordinate with cross-functional team including Quality, R&D, Production, Sales, and Service teams to ensure regulatory and quality compliance.
• Develop and deliver training programs on regulatory requirements and quality system topics.
• Ensure documentation and record management practices comply with 21 CFR 820 and 21 CFR Part 11 requirements.

Requirements

• Strong understanding of global medical device regulations and applicable standards.
• Demonstrated track record of consistent, high-level performance.
• Hands-on experience in Quality Management Systems (QMS), regulatory submissions, post-market surveillance (PMS), customer interaction, risk assessment, and adverse event management.
• Excellent analytical abilities with strong communication and project management skills.
• Proficient in Microsoft Word, Excel, and PowerPoint.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Engineering, Regulatory Affairs, Life Sciences, or related field.