Regulatory Affairs Specialist

About Cala Health

Cala Health is a bioelectronic medicine company transforming the standard of care for chronic disease. The company's wearable neuromodulation therapies merge innovations in neuroscience and technology to deliver individualized peripheral nerve stimulation, and its vertically integrated commercial model is reshaping the delivery of prescription therapies. Cala Health’s lead product, Cala Trio™, is the only non-invasive prescription therapy for essential tremor. New therapies are under development in neurology, cardiology, and psychiatry. Cala Health is headquartered in the San Francisco Bay Area and backed by leading investors in both healthcare and technology. For more information, visit CalaHealth.com.
 
The Opportunity

Cala Health is seeking a Regulatory Affairs Specialist to join our growing team, reporting to the Principal Regulatory Affairs Specialist. 
 
This role’s responsibilities include:

• Assists in preparation and review of regulatory filings
• Conducts 510(k) impact assessments for product changes
• Maintains Note-to-File history and updates technical documentation as needed in support of product changes/life cycle management and post-market data
• Monitors and coordinates maintenance of product regulatory certificates, business licenses, and establishment registration
• Assist in SOP development and review
• Serves as department archivist following document retention guidelines for key RA documentation
• Helps identify opportunities and implement process efficiencies
• Supports interdepartmental information requests
• Performs other regulatory-related duties as assigned.
• Support development teams through contributions to Design Control deliverables and review of technical design documents to ensure products meet regulatory objectives
• Support international regulatory efforts as needed, including Technical Files for Europe (CE Mark), global product registrations, etc.

Desired Skills and Experience

• A minimum of 2 years’ experience in Class II or Class III medical devices, including 510(k) or PMA submissions
• Demonstrated technical experience related to cross-functional Regulatory considerations, preferably in fields including neuromodulation, neurotechnology
• Experience in cloud-connected hardware or digital health (SaMD) is strongly preferred
• 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 communications and professional presentation skills and demeanor

Cala Health believes our success is based on diversity of people, teams and thinking. We offer all employees the tools, training and mentoring they need to succeed. Our selection process is driven by the key requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification. If you or someone you know might be interested in this position, please submit a resume & an
introductory email to [email protected].