Megha Sharma

Regulatory Affairs Specialist with 4 years of experience in the medical device industry. Adept at the following tasks: establishment licensing submissions, regulatory submissions for medical devices including new license applications and submitting amendments to Health Canada, EU MDR related projects, assessing change notifications, MDPRs, recalls and product complaint management.

Responsibilities and Achievements

• Monitor the notifications for changes routed in RIM under the MDS and MMS portfolios. Understand the NoC, ACR or change control, review the labeling documents, refer to the Canadian regulations and determine the impact of the change to complete the impact assessments for Canada.
• Meet with the local marketing team on a monthly basis to be informed about any upcoming new product launches. Share RECODE or EU MDR related updates with the marketing team after understanding the nature of the change. Consult medical affairs if needed and determine if it is a rolling change and the MDD product can be sold in the market or licensure of the MDR product is required. Develop a regulatory strategy to avoid any MDD product inventory builds.
• When regulatory submissions are planned, marketing and supply chain teams are informed immediately about the estimated submission timelines and expected date of Health Canada approval. This enables the supply chain team to forecast and plan inventory management.
• Coordinate with BU RA to obtain the required information and use it optimally to prepare the regulatory submissions for Health Canada.
• Prepared regulatory submissions: new licence applications and amendments for class II and III medical devices. Engaged in NHP submissions: site licence notifications and NHP site renewal application. Supported post market surveillance information requests from Health Canada.
• Assisted in establishment licence renewal and annual medical device licence renewal procedure. Extended support in the MDS bill 96 project and F202 submissions.
• Supported diabetes care spin off and have interacted with embecta about transition of products from BD to Embecta. Provided regulatory guidance, prepared and reviewed submissions to support the smooth transition.
• Efficiently communicate and coordinate with the stakeholders in regards to product launches, changes made to the product, special access devices and activation of products in ERP or discontinuation of products from licenses. Meticulous in providing regulatory perspective and inputs for field action letters and provision of information for RFPs.
• Built competence to use REP for drafting regulatory submissions. Efficiently used the FDA electronic submissions gateway/WebTrader account for regulatory transactions. Adept with creating and maintaining the licence, re-registration records and eIPRRA in RIM. Proficient with archiving submissions in Veeva Vault RA DMS.

Bachelor's in Biotechnology with 3.5 GPA.

Post graduate diploma in Advanced Biotechnology with 4.0 GPA.