Christopher M.
Experienced Medical Device Quality and Regulatory Leader
- Role
- Quality Assurance Regulatory Affairs Manager at Getinge
- Location
- Denver, CO, US
- LinkedIn followers
- 500 followers
About Christopher M.
I am a highly accomplished executive-level quality and regulatory affairs management professional with extensive experience providing leadership and guidance to drive the achievement of key organizational medical device-related goals and objectives. I am skilled at implementing strategy using quality best practices to create a quality management system to integrate internal processes and provide a process approach for project execution. In addition, I bring proven ability to develop strong, long-term relationships with key business stakeholders, used to draw alignment with key quality and regulatory affairs initiatives. I am continually recognized for the ability to deliver exceptional results leading in fast-paced, highly competitive medical device environments. Areas of Expertise Include:• Medical Devices • Organizational Leadership • Quality Assurance• Risk Management • Business Process Development • Quality Management System (QMS)• Manufacturing Processes • Quality Assurance Best Practices • Project Management• Continuous Process Improvement • Design & Process Validations • Product Development• Design Controls • Quality Management • ISO Certifications • Strategy & Execution • Regulatory Affairs • Mergers and Acquisitions• ISO 13485:2016, ISO 9001:2015, MDSAP, Medical Device Directive 93/42/EEC, EUMDR, SOR/98-282
Experience
Quality Assurance Regulatory Affairs Manager
Jul 2024 — Present · CO, US
Education
Arapahoe Community College
Mechanical Design, Mechanical Design
Colorado State University
Bachelor of Science - BS, Business Management - Organizational Development and Leadership
Skills
- Change Control
- Quality Auditing
- Gmp
- Quality System
- Quality Systems
- V&V
- Document Management
- Auditing
- Minitab
- Biotechnology
- Quality System Compliance
- Ce Marking
- Iso
- Sop
- Fda
- Cgmp
- Design Validation
- Regulatory Affairs
- Process Improvement
- Quality Assurance
- 510 K
- Process Development
- Complaint Handling
- R&D
- Design Controls
- Medical Devices
- Capa
- Iso 9000
- Quality Management
- Risk Management
- Continuous Improvement
- Compliance
- Problem Solving
- Manufacturing
- Spc
- Product Development
- Software Documentation
- Fmea
- Qsr
- Root Cause Analysis
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