Responsible for planning and executing global regulatory projects necessary to obtain and maintain global regulatory approvals
Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes
Identify factors that could impact the success or viability of new product launch in assigned market(s)
Monitor changes in regulations that impact current or future requirements and overall compliance
Communicate requirements of regulations to internal or external customers
Review and provide direction to ensure supporting evidence meets appropriate regulatory requirements
Complete and maintain varied regulatory filings by leading internal groups, collaborating with external groups
Manage individual projects by providing direction on diverse regulatory pathways
Assist in the review and development of processes related to regulatory activities

B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related
At least 4 years of experience in regulatory affairs in the medical device industry supporting domestic or international markets
Experience authoring and submitting regulatory submissions including 510(k)s and/or CE Technical Files
Experience preparing responses and communicating with regulatory agencies
Understanding of the current Regulatory environment and ability to perform within
Applied knowledge of FDA regulations and guidelines
Ability to evaluate information to determine compliance with standards, laws, and regulations

Senior Regulatory Affairs Specialist

About this role