Senior Regulatory Affairs Executive

Role & responsibilities

• 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.
• Labeling and Packaging: Ensure compliance with labeling and packaging regulations, including content, design, and format requirements.
• 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.
• Compliance Monitoring: Monitor compliance with company policies, procedures, and regulatory requirements, identifying areas for improvement and implementing corrective actions as needed.

Preferred candidate profile

• Bachelors / DPharma degree in a related field, related life science.
• 3-6 years of experience in medical device industry
• Minimum 4years 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.

Perks and benefits