Deepika Pathak

With nearly 4 years of experience as a Regulatory Affairs Specialist at Stryker, I am a dedicated professional well-versed in the intricacies of regulatory compliance within the medical device industry. Throughout my tenure, I have honed my expertise in areas such as label development, US FDA regulations, and EU MDR compliance.

My role has involved ensuring compliance with global regulatory requirements, particularly in the development and implementation of accurate and effective labeling strategies. I have successfully navigated complex regulatory landscapes, collaborating with cross-functional teams to secure regulatory approvals for product launches and updates.

Working closely with the US FDA and staying abreast of their evolving guidelines has been integral to my success. I have a strong understanding of FDA regulations and have demonstrated proficiency in preparing submissions, responding to inquiries, and managing regulatory audits.

Moreover, I have acquired extensive knowledge of the EU Medical Device Regulation (MDR), successfully guiding my team through the transition and implementation process. I possess a comprehensive understanding of MDR requirements, including technical documentation, conformity assessments, and post-market surveillance.

My commitment to excellence, attention to detail, and ability to adapt to changing regulatory landscapes have consistently ensured compliance and facilitated the smooth execution of projects. With a passion for regulatory affairs and a proven track record, I am ready to contribute my expertise to drive regulatory success within your organisation.

Skilled professional with background of computer engineering and deep knowledge of medical devices in health care. Skilled in Publication of Technical documents that is Labelling and Collateral documents.Working experience on EU MDR. Review and approval of documents. Creating database and maintenance of the same. Knowledge on SQL. ISO 13485 Certified, ISO 9001:2015. Knowledge on SAP, Power BI. Great customer facing and service experience.

Masters of Computers Application

Bachelors of Mathematical Sciences