Sr. Regulatory Engineer

Location: Skaneateles, NYDepartment: Regulatory AffairsRelocation Provided: YesEducation Required: Bachelors DegreeExperience Required: 6 - 10 yearsPosition Description:You will implement procedures and processes ensuring products meet regulatory requirements through development, market clearance, and post marketing phases for FDA Class I, II and III medical devices. Reporting to the Sr. Manager, Regulatory Affairs, responsibilities will include 510(k) submissions, Letters to File, Technical Files, CB Reports, technical construction files. It’s your life. Work well. You would be joining a privately held global manufacturer of innovative medical diagnostic equipment, cardiac defibrillators, patient monitoring systems and miniature precision light sources. Founded in 1915, Welch Allyn was recognized by Fortune Magazine as one of the Top 100 Great Places to Work.Position Requirements:A BS (Engineering preferred) and experience in a medical device, biotech, or highly regulated electronic manufacturing environment is required. Solid working knowledge of relevant medical device product safety and/ or telecommunication standards is needed for success. Knowledge of ISO-14001 and Human Factors is a plus. Your critical thinking, risk management and creativity have helped you find solutions for complex regulatory challenges. Your outstanding communication skills have enabled you to effectively influence positive change. Welch Allyn - What a Career Should Feel Like.Position Attributes:Your will create pre-market approval strategies, submit regulatory documents (e.g. 510(k)’s, PMA, Agency License(s)), approve labeling and interpret relevant clinical and safety standards. Representing Regulatory Affairs on Engineering, Manufacturing, Marketing, Quality, Clinical and Service cross-functional teams will help ensure all products are in compliance. You will also ensure compliance to post marketing surveillance regulations through evaluation and submission of adverse event reports. As you would expect with a global medical device manufacturer, you will be engaged to assure compliance of existing and new products to domestic and international regulations such as US Code of Federal Regulations, European Medical Device Directive, Canadian Medical Device Regulation, Australian TGA and Japan Pharmaceutical Affairs Law. Your knowledge of standards (e.g. UL, CSA, IEC 60601, JIS and ANSI/AAMI) are important in this regard. Your skills will help to support Quality Management System (QMS), assuring requirements of the FDA’s Quality System Regulation (QSR), ISO-13485 / CMDCAS and related standards are met..Additional Information: Travel Percentage: 10%