Tell us about your experience in providing regulatory input to product lifecycle planning and risk management.

In my previous role, I had the opportunity to provide regulatory input to product lifecycle planning and risk management. I worked closely with cross-functional teams to ensure that all regulatory requirements were met throughout the product development process. This involved conducting thorough research and analysis of regulatory guidelines and standards to ensure compliance. I also collaborated with regulatory authorities to obtain necessary approvals and certifications. Additionally, I actively monitored and assessed regulatory changes to identify potential risks and develop strategies to mitigate them.

In my previous role as a Regulatory Affairs Specialist, I played a key role in providing regulatory input to product lifecycle planning and risk management. I worked closely with cross-functional teams, including product development, quality assurance, and clinical affairs, to ensure that regulatory requirements were integrated into the product development process. This included conducting thorough research on global regulatory requirements, such as FDA regulations, EU directives, and international standards, and applying them strategically to ensure compliance. I also prepared and submitted regulatory documents, including pre-market notifications, 510(k) submissions, and technical files, with a high level of attention to detail and adherence to submission timelines. Additionally, I actively monitored regulatory changes and industry trends to identify potential impacts on product development and risk management strategies.

In my previous role as a Senior Regulatory Affairs Manager at a global medical devices company, I led a team responsible for providing regulatory input to product lifecycle planning and risk management. I developed and implemented strategies to ensure timely regulatory approvals and compliance across multiple jurisdictions. This involved collaborating with cross-functional teams to integrate regulatory requirements into the product development process and conducting risk assessments to identify and mitigate potential regulatory risks. One notable accomplishment was successfully guiding the company through a major regulatory audit, resulting in no major findings or non-compliance issues. I also mentored and coached junior regulatory professionals, fostering their growth and development. To stay abreast of regulatory changes and industry trends, I actively participated in regulatory conferences, workshops, and networking events, and I leveraged regulatory information systems and databases to access the latest regulatory updates and guidance.