Medical Device Regulatory Affairs Strategic Leader
hace 4 días
Overview
We are a health technology company driven by the belief that every human matters. Our mission is to provide access to quality healthcare for everyone, everywhere.
About the Role
As a Senior Regulatory Affairs Manager, you will play a key role in supporting our regulatory strategies and priorities for the International Sleep and Respiratory Care business. You will be responsible for ensuring compliance with domestic and international medical device product regulations, with a strong focus on new product development.
Responsibilities
- Support regulatory strategies and priorities for the International Sleep and Respiratory Care business.
- Ensure application of established policies and best practice regulatory standards within your area of responsibility for all filings, maintenance of existing product registrations, and agency interactions.
- Manage Regulatory staff by outlining regulatory strategy, setting work direction, and measuring performance.
- Provide regulatory training and strategic regulatory assessments to research and development teams in support of modern technology development.
- Act as a conduit for Q&A that may originate from business unit project teams, in-country/regional Regulatory Affairs teams, or governing regulatory bodies.
- Communicate business priorities to the Regulatory submissions team.
- Participate in discussions with business unit associates, both inside and outside of Regulatory Affairs, on country requirements.
Requirements
- Developing professional expertise and applying company policies and procedures to resolve a variety of issues.
- Advanced English communication skills.
- Fully qualified professionals with advanced beyond entry-level experience.
- Working knowledge of company products and services.
- Frequently interacts with functional peer groups.
Preferred Qualifications
- 5-10 years of experience in the medical device industry.
- Familiarity with regulatory documents and international registrations.
About Us
We believe that we are better together than apart. We encourage collaboration and teamwork to achieve our goals.
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