Join Cleerly as the Manager of Regulatory Compliance and ensure our innovative AI solutions in healthcare adhere to global standards. Collaborate with cross-functional teams to promote compliance and drive continuous improvement in a dynamic startup environment.
Key Responsibilities
Ensure compliance with global regulatory standards and internal QMS processes
Collaborate with various teams to align compliance systems and processes
Lead internal audits and identify improvement opportunities
Promote a culture of continuous readiness for audits
Interface for external audits and inspections
Manage MDSAP compliance program
Support compliance activities related to field actions and recalls
Contribute to regulatory intelligence efforts
Support Management Review and CAPA processes
Required Qualifications
10+ years in healthcare technology, life sciences, or similar regulated industries
Experience supporting or leading external audits and regulatory inspections
Collaboration, problem-solving, critical-thinking, and decision-making skills
Strong organization and management skills
Excellent interpersonal, communication, and presentation skills
Preferred Qualifications
Master's degree
Certification as a Lead Auditor for ISO 13485 or MDSAP
Additional credentials such as ASQ certifications or Lean Six Sigma Black Belt
Experience with agile development and cloud solutions