Opportunity Details

The Director of Regulatory & Medical Affairs in Malvern, Pennsylvania is responsible for managing Regulatory and Medical Affairs SOPs to ensure compliance with global regulatory requirements. This includes staying up-to-date on changes to relevant global regulatory standards and implementing those changes into company processes. The role involves working cross-functionally to ensure that new product development, clinical indications, and post-market activities meet internal processes and global regulatory standards. The Director will also develop strategies and oversee the creation, review, and editing of documentation for US and OUS regulatory submissions, as well as manage ongoing submissions such as annual reports and medical device registrations.

Additionally, the Director will support efforts in reviewing and approving product labeling, technical publications, and promotional materials to ensure regulatory requirements are met and product claims are properly supported. They will also oversee medical complaint handling, Safety Committee meetings, adverse event review, and reporting on a global scale. The Director will play a key role in ensuring safety warnings and precautions are adequate in all materials. Overall, the Director of Regulatory & Medical Affairs will be responsible for ensuring that the client complies with all regulatory standards and processes, both domestically and internationally.

In summary, the Director of Regulatory & Medical Affairs in Malvern, Pennsylvania will be responsible for managing Regulatory and Medical Affairs SOPs, staying current on global regulatory standards, and ensuring compliance with internal processes. They will oversee the creation and review of documentation for regulatory submissions, manage ongoing submissions, and support efforts in reviewing product labeling and promotional materials. The Director will also oversee medical complaint handling, Safety Committee meetings, adverse event review, and reporting globally to ensure safety warnings and precautions are adequate. The role is crucial in ensuring that the client meets all regulatory requirements and standards in the development and marketing of products.