Vice President of Regulatory Affairs
Your tasks as the Vice President of Regulatory Affairs:
- Provides decisive leadership and strategic direction and serves as the point of contact for Global Regulatory Affairs for the organization both internally and externally.
- Actively participates as a member of the Senior management team to ensure the strategy and vision of Global Regulatory Affairs supports the strategic vision of the company.
- Serve as a primary contact for International authorities and other Health Authorities.
- Provides oversight, and appropriate hands-on management of all global regulatory needs.
- Effectively manages regulatory resources to strongly support all business development in support of corporate goals and timelines
- Designs, implements and expands corporate processes and procedures to ensure consistently high quality, timely submissions
- Advise and design internal training courses on GMP and related topics
Field of responsibility for the Vice President of Regulatory Affairs:
- The VP of Regulatory Affairs is the key executive leader who provides the vision, strategic direction and corporate regulatory approach for all products. This individual is responsible for the analysis and evaluation of domestic and global regulatory guidelines and requirements, and
- Focus on the mentoring, growth and development of the regulatory staff
- Provide strategic insight that efficiently and effectively translates regulatory requirements into practical plans.
- You will be accountable for the timely preparation of high quality, organized and scientifically valid regulatory submissions and for ensuring the corporation is inspection ready at all times.
- It is expected that this individual will significantly contribute to the continued development of an efficient and effective regulatory support infrastructure and the further implementation of standardized processes and procedures.
- A scientific related degree
- Minimum of 10 years experience in Regulatory Affairs across Medical Device or IVD
- Strong problem-solving skills for developing innovative approaches and meeting project objectives
- Strong People Management Experience