Job Information
Siemens Medical Solutions USA, Inc Regulatory Affairs Professional in Issaquah, Washington
Company: Siemens Medical Solutions USA, Inc. Location: 22010 SE 51 st St. Issaquah, WA 98029 Position Title: Regulatory Affairs Professional Salary: $151,386 - $171,840 / Year Hours: Monday - Friday, 8:00 am to 5:00 pm, 40 Hours/ Week Summary of Duties: Provide regulatory information and guidance for catheter and product development and planning throughout the product lifecycle. Regulate planning for new catheter and product introductions and changes. Assist in maintaining regulatory compliance. Plan and prepare catheter and product related medical device submissions with Siemens internal or external organizations according to regulatory requirements. Submit required documentation and information to local authorities or Siemens internally. Advise project steering groups on regulatory strategy and requirements for new products and solutions. Identify potential regulatory approval risks based on changes in regulations, standards, country specific issues or other unique characteristics of the project. Identify, analyze, and implement country specific requirements necessary for catheter and product related submission. Review promotional material and products that are introduced into a market for regulatory com pliance according to country specific requirements. 10% Domestic and International travel required. Hybrid work permitted, must report to the Company's office in Issaquah, WA at least 3 days/week. Qualifications: The position requires a Bachelor's degree in Biomedical Engineering, Electronic Engineering, Computer Engineering, or a related field and eight (8) years of experience in the job offered or an acceptable alternate occupation. Employer will accept a Master's degree in Biomedical Engineering, Electronic Engineering, Computer Engineering or a related field and six (6) years of experience in the job offered. The position requires extensive experience with the following skills: Regulatory Experience in medical devices; Experience with global medical device regulations and registration processes, including USA 510(k) and EU MDR for Class IIa & III. The position requires three (3) years of experience with the following skills: International standards experience, including IEC 60601-1, 60601-2-37, ISO 10993 and ISO 11607; Experience with relevant procedures, practices, packaging, sterilization, biocompatibility and associated medical terminology. 10% Domestic and International travel required. Hybrid work permitted, must report to the Company's office in Issaquah, WA at least 3 days/week. THIS NOTICE IS BEING POSTED IN CONNECTION WITH THE FILING OF AN APPLICATION FOR PERMANENT ALIEN LABOR CERTIFICATION. ALL APPLICANTS SHOULD REPORT DIRECTLY TO THE EMPLOYER. ANY PERSON MAY PROVIDE DOCUMENTARY EVIDENCE BEARING ON THE APPLICATION TO THE REGIONAL CERTIFYING OFFICER OF THE DEPARTMENT OF LABOR AT THE FOLLOWING ADDRESS: US Department of Labor Employment and Training Administration Office of Foreign Labor Certification 200 Constitution Avenue, NW, Room N-5311 Washington, DC 20210 Equal Employment Opportunity Statement Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by f To view the full job description,