The position will be responsible for managing all necessary U.S. FDA pre-market clearances relating to human and animal registrations and drug listings, and medical device section 510(k) approvals with U.S. FDA and all U.S. state drug/medical device registration offices.In addition, the position will be the key company interface with U.S. FDA and provide strategic direction to Marketing, RD, Operations, and Sales to facilitate speed to market and maintain compliance with applicable regulatory requirements.



Main Responsibilities:


 Coordinate, prepare, submit, negotiate, and secure necessary U.S. FDA pre-market authorizations to support speed to market of new FDA-regulated products. 
 Manage FDA-regulated products in strict compliance with FDA and state requirements, thereby preventing risks of interrupted sales and enforcement actions. 
 Provide leadership and support to Marketing and RD regarding product development, cost-effective data generation, product labeling, and registration timelines for product launches of FDA-regulated products, including interaction with other Ecolab personnel on global product authorizations. 
 Develop excellent relationships with FDA staff and applicable registration agencies. 
 Analyze and communicate to Ecolab senior management the costs of registrations and proposed/revised U.S. regulations regarding product registration impact.In coordination with Government Affairs, proactively influence regulation rulemaking processes from a competitive standpoint to minimize adverse impacts on Ecolab. 
 Manage staff responsible for state registrations to assure strict compliance with applicable regulations and requirements for drug, animal drug, medical device, cosmetic, and related tax or similar requirements. 
 Manage new and updated corporate quality system procedures (RQS) encompassing FDA product design and development requirements. 


Key Qualifications:



 BS in chemistry, microbiology, biology, chemical engineering, environmental sciences, or related field - Masters degree in chemistry, biology, microbiology, environmental science or related field preferred 
 Excellent written and oral communication skills 
 Excellent database management skills 
 Detail oriented 
 Ability to drive others to get things done 
 Must be able to excel in a fast-paced team environment 
 Knowledge of FDA regulations, work experience with FDAs drug/medical device/cosmetic requirements.Familiarity with governmental regulatory programs such as EPA, FDA, OSHA, DOT, and other state regulations preferred 
 Experience working directly with legal, RD, operations, and marketing departments preferred 
 EPIC system experience preferred 
 Technical writing experience preferred 


 AutoReqId 12301BR

 


 

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