Senior Manager, Global Device Quality
Core
Provide global leadership to establish, maintain, and implement Viatris' Global Quality Standards for medical devices and combination products, ensuring compliance with global regulatory requirements.
Role type
Senior Manager, Global Device Quality
Builds
Global Quality Management Systems and compliant practices for medical devices and combination products
Domain
Healthcare / Medical Devices / Regulatory Affairs
Required skills
Global cGMP regulations, Medical device regulatory requirements (EU MDR, FDA), Quality Management Systems, Conformity Assessments, Regulatory submissions (510(k), CE), CAPA management, Supplier management, Team leadership, Strategic planning
Preferred skills
Experience with Pharmacovigilance, Audit response, Regulatory trends analysis
Technologies
Microsoft Office (Word, Excel, Outlook)
Responsibilities
Provide leadership and drive continuous improvements in quality system practices; Align with top-level managers on corporate-wide Quality initiatives; Serve as a subject matter expert on QMS and Conformity Assessments; Evaluate and implement systems for standardizing compliant practices; Participate in global inspection preparedness and audit response; Interact with Regulatory Authorities and lead medical device submissions; Ensure compliance with post-market surveillance and vigilance requirements; Act as Person Responsible for Regulatory Compliance (PRRC); Collaborate with quality colleagues and other departments during integration activities; Monitor regulatory trends and identify best practices; Create, review and improve global SOPs and policies; Review and approve site SOPs
Seniority
Senior, hands-on IC with leadership responsibilities