Key Responsibility:

• Having extensive knowledge of regulatory pathways for medical devices approvals in various countries with primary focus on US & European regulatory pathways.
•  Ability to research data and develop a regulatory strategy for approval of products for
•  medical device manufacturers. Experience in creating and documenting a regulatory strategy successfully will be a plus.
•  Should have knowledge of USFDA establishment registration & device listing.
• Ability to write 510(k) and PMA applications with relevant information and input from the engineer in teams.
• Experience with preparing design & development documentation to align with the regulatory strategy.
• Experience for compilation of technical file/design dossier as per USFDA and CE guidelines.
• Need to do documentation as per FDA & CE-MDR regulations and ISO standards.
•  Perform audit compliances, analysing gaps, shortcomings as per FDA/ISO regulations. •
• File Annual reports and manage regulatory changes per the respective FDA and CE mark guidelines.
•  Understanding of cGMP regulations per 21 CFR and ISO 13485. Understanding of Risk Management per ISO19471.
• Specific Skill
• Bachelor’s in Pharma with 4+ years of experience OR Master’s in Pharma with 2+ • years of experience.
• Technical writing, English communication and teamwork.
•  Detail oriented, ability to read various standards and guidelines & define
• General Skill
• Strong attention to detail and documentation accuracy.
•  Good understanding of engineering documentation practices.
• Ability to work with cross-functional engineering teams.
•  Effective communication and documentation skills.
•  Critical thinking and problem-solving skills.
•  Excellent communication and collaboration skills.
•  Must be a Team Player.