The Opportunity 

Cala Health is seeking a Sr. Regulatory Specialist to join our dynamic team. You will play a pivotal role in advancing our innovative medical solutions by ensuring regulatory compliance. Specific responsibilities include preparing and managing regulatory filings, developing and implementing regulatory strategies, and maintaining company compliance with regulatory standards. You will collaborate closely with research, development, digital, and commercial teams, ensuring that all regulatory processes are integrated into the broader company objectives. 

This role is onsite at our San Mateo office. The compensation for this role is market driven with a salary range of $120,000 - $180,000. Additionally, we offer a robust benefits package. This offering is aligned with our overall compensation philosophy. 

Specific Responsibilities include: 

• Prepare and manage regulatory filings on new products and changes to existing products in Cala’s portfolio, including 510(k) submissions, de novo submissions, requests for Breakthrough Designation, and other filings 
• Contribute to regulatory research and strategic assessments for cross-functional project teams including research, development, digital, and commercial teams 
• Implement regulatory strategies in alignment with business goals and objectives 
• Support development teams through contributions to Design Control deliverables and review of technical design documents to ensure products meet regulatory objectives  
• Support commercial teams through review of product and marketing documents  
• Prepare materials and participate in meetings with regulatory bodies and notified bodies 
• Support international regulatory efforts as needed, including Technical Files for Europe (CE Mark) 
• Monitor and analyze regulatory changes and trends to keep the company informed and compliant 
• Assist in the preparation and facilitation of regulatory audits and inspections 

Required Skills and Experience 

• Minimum BA/BS degree in a life sciences or related field  
• Minimum of five (5) years of regulatory affairs experience in Class II or Class III medical devices, including 510(k), de novo, or PMA submissions to FDA 
• Working knowledge of US and international regulatory requirements and standards 
• Proven technical experience related to cross-functional regulatory considerations, preferably in neuromodulation or neurotechnology  
• Experience in cloud-connected hardware or digital health (SaMD)  
• Demonstrated experience developing innovative and compliant regulatory approaches to solving complex and novel regulatory needs 
• Strong interpersonal skills and passion for building positive, collaborative, and productive relationships both internally and externally 
• Adaptable mindset with enthusiasm for the challenges of balancing and strategically prioritizing competing needs
• Excellent written and verbal communication and professional presentation skills and demeanor