Naresh A Email & Phone Number

I am actively seeking new opportunities where I can apply my expertise in Design Controls, Risk Management, and Regulatory Affairs, backed by my comprehensive training from Conestoga College. In my previous roles, I’ve worked extensively in the medical device industry, ensuring compliance with industry standards such as ISO 13485, FDA 21 CFR Part 820, and EU MDR while improving product safety through robust design and risk management practices.My expertise lies in remediating Quality Management Systems (QMS), driving continuous improvement, and enhancing manufacturing processes to streamline workflows. I’ve collaborated with cross-functional teams to maintain the accuracy and integrity of Design History Files (DHFs) and Device Master Records (DMRs), ensuring that all documentation complies with regulatory requirements. In addition, I’ve supported cybersecurity initiatives throughout the product lifecycle, contributing to risk mitigation and overall product security.With a strong foundation in Regulatory Affairs, I have demonstrated success in working on remediation projects, risk management analysis, and compliance with Good Manufacturing Practices (GMP). I am committed to fostering cross-functional collaboration to optimize product development cycles, improve quality outcomes, and ensure timely regulatory submissions.As I continue to grow professionally, I am open to new opportunities where my background in quality assurance, regulatory compliance, and continuous improvement can contribute to high-performing teams in medical devices or related industries.