Sr. Regulatory Engineer III

Company: Welch Allyn Job ID: 3325 Position Title: Sr. Regulatory Engineer III



Company: Welch Allyn


Job ID: 3325


Position Title: Sr. Regulatory Engineer III


Working Location: Portland/Beaverton


Employment Group: Full-Time Regular


Required Experience: 11 - 15 years


Required Education: Bachelors Degree


Travel Percentage: 10


Position Overview: Reporting to the Manager, Regulatory Affairs, you will ensure timely completion of all worldwide regulatory activities relating to product compliance, marketing clearance and certification of FDA Class I, II and III medical devices. Your knowledge of 510(k) submissions, Letters to File, Technical Files, CB Reports and technical construction files will be integral aspects of this career opportunity. Your responsibilities will include compliance of all existing and new products to domestic and international regulation such as EU MDD, Canadian Medical Device Regulation, Australian TGA, UL, CSA, IEC, JIS, ANSI/AAMI as well as assuring compliance to regulations. You will support compliance of the quality systems to the requirements of the FDA?s Quality System Regulation, ISO-13485/CMDCAS. ISO 14971 and related standards.


Key Responsibilities: Your focus will be on the coordination of all submission activities with respect to planning, scheduling, coordinating and submitting regulatory documents (e.g. 510(k)?s, PMA, Agency License(s)) based on your thorough knowledge of FDA regulations, guidance?s and international licensing requirements. You will represent Regulatory Affairs and assure proactive relationship in various cross-functional meetings and project teams with Engineering, Manufacturing, Marketing, Quality, Clinical Affairs and Service groups to ensure that all products are and remain in compliance. Review and approve product labeling to ensure accuracy and supportability of claims and to ensure fulfillment of product label requirements. Thorough review of complaints and service reports you will aid in the preparation and submission of adverse event to the appropriate affected regulatory bodies. You will also support EMC compliance efforts in interpretation of EMC and telecommunication standards with respect to the Medical Device and Radio/Telecommunications Directives, as well as FCC, Industry Canada and related international standards. While adhering steadfast to compliance policies and procedures, you possess the ability to work in a dynamic environment that empowers teams and leads the regulatory initiative.

As a Senior Regulatory Engineer you will develop ROI Analysis on projects to determine cost effective methods for obtaining and performing product evaluations and approvals. The previous skill sets you have mastered will assist in the development and promotion of the Corporate quality systems and philosophy as well as defining, maintaining and updating standards, methods and procedures. Your ability to analyze and resolve highly complex quality requirements while retaining a high level of creativity and resourcefulness will key indicators of your success. Utilizing your excellent verbal and written communication skills will allow you to identify and execute regulatory projects to ensure areas of responsibility are streamlined and are business and user friendly.


Required Background: MS/BS degree in Engineering coupled with ten years of overall experience working in a medical device, biotech, or highly regulated electronic manufacturing environment required. Strong working knowledge of US FDA and international quality system requirements, Medical Device Directive, medical device product safety standards and telecommunication standards are needed for this position. Knowledge of ISO-14001 and Human Factors is a plus. Meeting deadlines and working overtime is required. Must have the flexibility to travel as necessary.