DGM - Regulatory - Device

About this role

Responsibilities

• Develop and maintain end-to-end regulatory strategies for key markets
• Manage preparation and submission of regulatory dossiers such as 510(k) and PMA
• Oversee post-approval submissions and lead change impact assessments for design modifications
• Assess clinical and preclinical testing data to meet regional regulatory expectations
• Act as the primary regulatory point of contact for agency questions and deficiencies