The main purpose of your job will be to ensure that a Complex Manufacturing & Supply Operations (CMSO) Quality Compliance System is in place, securing compliance of activities, quality risk management, escalation of risks, and continuous improvement
Key responsibilities of the Compliance Specialist include:
- Input, Review, and Endorsement of Core Activities for Combination Products and Medical Devices Throughout Product Lifecycle: Development, Launch, and Commercialization
- Engage in Corporate Standards Processes
- Support the Implementation of the Site Inspection Readiness Program
- Support the Implementation of Quality Risk Management
- Provide Expertise, Guidance, and Support of NTMs and GNTMs
- Train Site Colleagues on the Corporate Standard System
- Request Support as a Member of the Global Compliance Network
Key requirements of the Compliance Specialist include:
- Minimum BSc in Medical Engineering/Medical Technology (preferred), or further science-based degree
- Combination Product and/or Medical Device expert/SME
- 10+ years as a functional leader in the industry
- Advanced knowledge of Combination Product/Medical Device-related current and upcoming legislation and industry best practices
- Advanced understanding and insight into the different aspects of quality functions like QC, QA, Quality Systems, Compliance, Documentation, etc
- Effective negotiation skills, strong interpersonal skills, excellent presentation skills
- Fluent English, further languages preferred
