Michelle N.
About Michelle N.
Michelle N. is a Regulatory Affairs Manager at Boston Scientific with over a decade of experience in the medical device industry.
Regulatory Affairs Manager at Boston Scientific
Michelle N. serves as the Regulatory Affairs Manager at Boston Scientific since 2021. In this role, she is responsible for overseeing regulatory submissions and ensuring compliance with relevant healthcare regulations. Her work involves managing regulatory strategies and maintaining clear communication with regulatory agencies to facilitate the approval and ongoing compliance of medical devices.
Experience in Medical Device Industry
With over a decade of experience in the medical device industry, Michelle N. has accumulated extensive knowledge and expertise. Her comprehensive background includes various facets of the industry such as regulatory affairs, quality management, and strategic execution of business practices. This experience has solidified her understanding of both operational and regulatory requirements needed for successful product development and market introduction.
LEAN Business Practices and Strategic Imperative Execution
Michelle N. is proficient in LEAN business practices, which involve streamlining processes to eliminate waste and improve efficiency. Additionally, she has a strong track record of executing strategic imperatives, ensuring that business objectives align with regulatory requirements. These practices contribute to the overall efficiency and regulatory compliance of the organization.
Acquisition Integration and Supplier Quality Management
Her skills extend to effective acquisition integration and management, vital for smooth transitions during corporate expansions and mergers within the medical device industry. Michelle N. also excels in managing supplier quality, ensuring that all suppliers meet stringent quality standards. This capability is critical in maintaining the overall quality and safety of medical devices.
Regulatory Submissions and Complaint Management
Michelle N. has a strong capability in handling regulatory submissions, ensuring that medical devices meet all necessary regulatory requirements for market approval. She is also adept at managing complaints, utilizing robust systems to address and resolve any issues that arise, ensuring continued compliance and customer satisfaction.