Senior Regulatory Affairs Program Specialist

• Leading collaboration with cross-functional stakeholders to ensure regulatory compliance is met
• Acting as the technical liaison between cross-functional departments and the Regulatory Affairs team
• Evaluating and resolving regulatory and technical issues due to extensive knowledge of medical device manufacturing
• Leading technical medical device compliance initiatives
• Driving education of regulatory compliance to key business stakeholders
• Reviewing global regulatory submissions for technical accuracy and regulatory compliance
• Supporting technical inquiries for medical device regulatory submissions, registrations, licenses, clearances, approvals, and deficiencies
• Collaborating with Engineering and R&D to develop the standards strategy for medical devices
• Participating in regulatory audits/inspections as required
• Authoring and maintaining standard operating procedures (SOPs) and training key personnel

• Bachelor's Degree required
• 5+ years of regulatory experience in the Medical Device Industry required
• Previous experience working with Regulatory Authorities relative to premarket and compliance activities required
• Project management skills
• Must be able to work under pressure to meet regulatory reporting time frames and company requirements
• Must be able to work with minimal supervision, recognize departmental needs and initiate/recommend actions for resolution
• Experience interacting with FDA and/or other regulatory agencies
• Proven analytical abilities, able to apply problem-solving skills for problems of moderate to diverse scope
• Understanding of manufacturing and change control, and an awareness of regulatory trends
• Understanding of engineering concepts and scientific terminology
• Documented evidence of writing skills
• Strong understanding of medical terminology

Demonstrates extensive regulatory experience in the Medical Device Industry, with a strong focus on compliance initiatives, technical liaison capabilities, and project management. Proficient in authoring standard operating procedures and engaging with regulatory authorities to ensure adherence to industry standards.