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Regulatory Affairs Advisor
The Regulatory Affairs Advisor provides professional engineering services. In general, the Regulatory Advisor is responsible for providing guidance on and executing regulatory, clinical study and Quality Assurance activities.
- Provides guidance on establishment and maintenance of quality systems that are in compliance with FDA Quality System Regulation, ISO 13485, MDD/MDR and other international requirements;
- Provides guidance on U.S. and international regulatory strategy for new products in development and changes to existing products;
- Provides guidance on the requirements for human clinical trials to support U.S. and international regulatory strategies for new products in development and changes to existing products;
- Provides guidance on and prepares U.S. and international regulatory submissions for new products in development and changes to existing products;
- Maintains awareness of current and proposed FDA and international regulations and standards changes and communicates this information to the company as required to assure the company maintains compliance.
DESIRED KNOWLEDGE, SKILLS AND ABILITIES
- A bachelor’s degree and 7+ years of related experience OR an equivalent combination of education and experience is required.
- Must be a specialist on complex technical and business matters.