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Joshua Kim Senior Regulatory Affairs Engineer Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 Tel. (315) 554-5289 Fax (315) 685-2532 e-mail: [email protected] web: www.welchallyn.com Company: Welch Allyn Requisition Number: 2507 Posting Date: 2/1/2005 10:47:54 Position Title: Senior Regulatory Affairs Engineer Working Location: Skaneateles, NY - State Street Department: Medical Quality Control Salary Grade: 60 Required Experience: 6 - 10 years Required Education: Bachelors Degree Required Travel: False Travel Percentage: 0 Relocation Authorized: Yes Position Overview: Your knowledge of the decision making process on regulatory submission issues for medical devices enables your effective interface with the FDA and international health authorities as appropriate in this effort. You will also review promotional material and device labeling for regulatory compliance. An ability to conduct and co-coordinate engineering investigations, inspections, audits, and corrective actions will be of benefit in any MDR or recall situations. Your ability to collaborate with R&D and Manufacturing to ensure product compliance to electrical safety standards is essential to guiding regulatory projects, and schedules.. In this career opportunity, you will assist communication and coordination with regulatory agencies and maintain standards updates / revisions, and product registration activities. Knowledge of 510(k) submission documents and processes with respect to planning, scheduling, coordinating and submitting regulatory documents is a key to success. Key Responsibilities: Welch Allyn is a leading global manufacturer of frontline medical products and solutions focused on advancing frontline care. And after 90 years of steady global growth, we continue to strengthen our position as a market leader through a commitment to quality and innovation. In 2003, Fortune Magazine rated us one of the 100 Best Companies to Work For --- because at Welch Allyn we know what a career should feel like. As a Sr. Regulatory Engineer, reporting to the Worldwide Director Regulatory Affairs, you will use your regulatory planning and strategy experience to develop and support 510K Submissions and PMA submissions required for FDA approval of new or modified Class II or Class III medical devices, with emphasis initially on the Canadian market. Required Background: An Engineering degree and experience in a medical device, biotech, or highly regulated electronic manufacturing environment, as well as knowledge of IEC 60601 for electrical safety, and familiarity with FDA QSR, ISO-13485, EN-46001, and ISO-9001 is needed. In addition to opportunities to improve healthcare around the world Welch Allyn provides the culture, reward, challenge, and growth you would expect from a world class company of motivated, friendly people. It's your life. Work well. Company: Welch Allyn Requisition Number: 2509 Posting Date: 2/1/2005 12:13:51 Position Title: Regulatory Affairs Engineer Working Location: Skaneateles, NY - State Street Department: Medical Quality Control Salary Grade: 55 Required Experience: 3 - 5 years Required Education: Bachelors Degree Required Travel: False Travel Percentage: 0 Relocation Authorized: Yes Position Overview: Welch Allyn is a leading global manufacturer of frontline medical products and solutions focused on advancing frontline care. And after 90 years of steady global growth, we continue to strengthen our position as a market leader through a commitment to quality and innovation. In 2003, Fortune Magazine rated us one of the 100 Best Companies to Work For --- because at Welch Allyn we know what a career should feel like. As a Regulatory Engineer, reporting to the Manager Regulatory Affairs, you will have a major focus on "back end" regulatory product vigilance activities. A key responsibility will be ensuring compliance of all existing and new products to domestic and international regulations such as EU MDD, UL, CSA, IEC, JIS, as well as assuring compliance to regulations, which are specific to product mix. Key Responsibilities: Investigations, inspections, audits, and corrective actions as they relate to Medical Device Reporting (MDR), recalls, and complaint handling will help you to ensure product compliance not only to regulations, but also to appropriate electrical safety standards. You will also partner with R & D design teams and provide input on design verification, design validation, reliability, requirements traceability, hazard analysis, etc as relates to regulatory licensing and submissions of 510(k). You also posses knowledge of the regulatory submission processes for medical devices, and are able to effectively interface with the FDA and other relevant health authorities in this effort. Required Background: An Engineering degree and experience in a medical device, biotech, or highly regulated electronic manufacturing environment, knowledge of IEC 60601 for electrical safety, and familiarity with FDA QSR, ISO-13485, EN-46001, and ISO-9001 is needed. In addition to opportunities to improve healthcare around the world Welch Allyn provides the culture, reward, challenge, and growth you would expect from a world class company of motivated, friendly people. It's your life. Work well. This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. 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