Vice President Global Regulatory Affairs
My client is a medical device company with a global platform and offices in 32 countries. They have retained us to fill a confidential search for their newly created Vice President of Global Regulatory Affairs position. Within their unique culture of innovation and collaboration, you will have the ability to come in to and be the architect of a growing regulatory department. You will get true global experience in an established company, while helping their 20,000,000 patients worldwide.
Responsibilities:
- Lead the development and execution of regulatory strategies and tactics to support business objectives and optimize the outcomes of interactions with global regulatory agencies/authorities for the life of the product (pre and post market)
- Develop and execute regulatory strategies and plans in support of corporate goals and objectives
- Direct and manage preparation, submission and maintenance of regulatory files to ensure high quality regulatory submissions to competent authorities such as FDA, TGA, CSA, Health Canada, Brazil, Japan various Foreign governments and European Notified Body
- Lead the management, resourcing and continuous improvement of all aspects of global Regulatory Affairs function including developing talent, capability, process and systems improvements
- Lead the global Regulatory Affairs function so new products developed within the group comply with relevant global Medical Device Regulations, applicable standards and internal policies, whilst minimizing time to market
Knowledge and Skills:
- Minimum BS in science or engineering; advanced degree preferred
- 10+ years related experience with a medical manufacturer
- Demonstrated ability and drive, build, coach, and motivate a high performing team
- Effective process and project management skills
- Working knowledge of Quality Management Systems
- International global regulatory experience