Job Description

Job Requirements

• Regulatory Compliance: Ensure that company products and processes comply with relevant regulations, such as FDA (21 CFR Part 820), ISO 13485, EU MDR, IEC 62304 and other global standards.
• Submission Preparation: Prepare and submit regulatory submissions, including 510(k) notifications, PMA applications, IDEs, and post-market surveillance reports.
• Analyze the regulatory needs and customer requirements on active medical devices on electrical, mechanical and software components.
• Responsible for owning & leading entire Medical Device for remediation according to customer requirement.
• Execute the remediation project by guiding the remediation engineers.
• Review of the artifacts modified or prepared for remediation projects.
• Prepare technical documentation dossiers for regulatory submissions, including design controls, risk management plans, and performance testing data.
• Product Development: Collaborate with cross-functional teams to develop new products, ensuring regulatory compliance throughout the product lifecycle.
• Audits and Inspections: Coordinate internal audits and prepare for FDA inspections by ensuring compliance with regulations and maintaining accurate records.
• Manage the regulatory submission process for new and existing medical devices, working closely with notified bodies and regulatory agencies.
• Track regulatory timelines and milestones, ensuring timely submissions and approvals.



Work Experience

• Bachelor's / master's degree in a related field, such as biomedical engineering, Mechanical Engineering, Electrical and Electronics Engineering or related life science.
• 7-12 years of experience in medical device industry
• Minimum 8 years of experience in medical device regulatory affairs, preferably with experience in the active medical device (Entire life cycle).
• Hands on experience in DHF Gap Assessment and Remediation for FDA 21 CFR Part 820, EU MDR.
• Experience working in Class II or Class III products preferred.
• High exposure to prepare/correlate regulatory compliance of active medical devices in full lifecycle.
• Able to understand the regulatory needs and customer requirements on active medical devices on electrical, mechanical and software components.
• Strong leadership and mentoring skills, with the ability to guide junior team members and lead cross-functional projects .
• Ability to interpret complex regulations and guidelines, applying that knowledge to practical scenarios.
• Familiarity with computerized systems, such as electronic submission systems (e.g., FDA's eSubmitter).