Partial Job Description
1) Design, plan and execute regulatory strategies for timely and high quality submissions in close collaboration with marketing, product development, manufacturing, clinical affairs and legal partners for optimum achievement of corporate objectives
2) Manage the regulatory affairs departmental budget
3) Provide overall management and training direction to the regulatory affairs team
4) Interact with medical device regulatory agencies
5) Provide expertise in the interpretation of FDA regulations and regulatory advice to other departments and executive management
6) Maintain international certifications (ISO 13485:2003) for all manufacturing facilities
7) Coordinate on regulatory affairs with outside regulatory advisers and counsel
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