AutoReqId 48847BR External Job Title Sr Regulatory Specialist I Functional Area Law Sub-Function Regulatory Affairs City St Paul State/Province Minnesota Country United States Employment Type Full-Time Job Description Ecolab is seeking an experienced Sr. Regulatory Specialist to support global innovation projects for surgical electromechanical medical devices. This position will support new product development and provide on-going regulatory support for electromechanical medical device equipment as well as the sterile, single use disposables that are used and marketed with the equipment. Ecolab Healthcare develops and markets various sterile surgical medical devices; preparation of Technical Files and sterile product labeling for these devices is also required. Main Responsibilities Serve as core Regulatory team member on surgical new product development teams providing RA guidance and project regulatory assessments and regulatory plans. Communicate and coordinate regulatory activities with other functions such as Research and Development, Quality Assurance, Marketing and Supply Chain/Sourcing; actively collaborate and further project goals. Majority of Project Team members and functions are located remotely; therefore must be effective with remote team meeting participation, collaboration and communication. Conducts reviews and approvals of protocols, reports, assessments, risk documentation and all DHF project documentation as well as product labeling. Author Technical Files and 510(k) s for new product designs for submission to Notified Body and US FDA. Prepare detailed documentation for obtaining and renewing CE marking certification. Update Technical Files on an on-going basis. Review device labeling and promotional materials for compliance to Regulatory requirements and verify supporting data to substantiate any product performance claims. Partner and collaborate with Ecolab European Regulatory Affairs colleagues regarding projects, current EU regulations and Technical Files. Excellent verbal and written communication skills with a high level of expertise in writing clear and concise Regulatory submissions. Experience and Education BS in Engineering/Sciences; Mechanical Engineering or Electrical Engineering preferred. 7+ years' experience in the medical device industry with minimum of 4 years Regulatory experience with electromechanical medical devices and sterile single use disposables. Experience with WEEE and RoHS compliance Experience with Risk Assessments and testing to IEC 60601-1 3rd edition, IEC 60601-1-2, IEC 60601-1-6 and IEC 62366 Experience with EU, US FDA and Canadian medical device regulations and submissions About Ecolab Every day, we make the world cleaner, safer and healthier - protecting people and vital resources. Ecolab is the global leader in water, hygiene and energy technologies and services. Around the world businesses in foodservice, food processing, hospitality, healthcare, industrial, and oil and gas markets choose Ecolab products and services to keep their environment clean and safe, operate efficiently and achieve sustainability goals. Our global workforce of over 44,000 employees is consistently delivering comprehensive solutions that meet the unique needs of our customers.