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WELCOME

As the chair of the RAPS Wisconsin Chapter, I'd like to personally welcome you to the RAPS community! By being a member of RAPS, not only are you connected to 14,000+ regulatory professionals worldwide, but you also have access to a vibrant regulatory community right here in your geographic region.

The RAPS Wisconsin Chapter conducts a number of professional development and networking activities throughout the year to help members connect, build relationships and increase knowledge, competence and performance. RAPS is a volunteer-driven organization, and I’ve found that the more I put into it, the more I get back. There are a number of volunteer opportunities available at the chapter and national levels, and I am happy to help you identify something that meets your interests and serves your personal growth needs.

If you are a RAPS member, log in for full access to the chapter member directory and the discussion board. Members residing outside of the chapter served region can find and join a chapter's online community from the chapter community listing.

We hope you will join us at our next event. I look forward to introducing you to some of our other members and volunteers. Again, welcome to RAPS and please let me know if I can be of assistance.

Sincerely,

Lisa Baumhardt
Chair, Wisconsin Chapter

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Chapter Sponsors

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Chapter Discussion Board

Volunteer Spotlight

Volunteer Spotlight
Each month, RAPS turns the spotlight on a member making an impact in RAPS and on the regulatory community. These members are the backbone of the Regulatory Affairs Professionals Society and an inspiration for others. If you are interested in being highlighted or nominating another member for the spotlight, please contact Austen Gage at agage@raps.org.

Local Regulatory Job Openings

  • Washington DC, D.C., The Promise Starts with YOU   At the Johns Hopkins Health System, we believe in The Promise of Medicine.  It is exciting, dynamic, and starts with our exceptional team. Join us, and help set the standard of EXCELLENCE in clinical care, research and education   Discover what is possible when you bring your passion to the TEAM!   In collaboration with the Senior Director, Patient Safety and Quality Improvement, is responsible for providing leadership and oversight for development, management, coordination, integration and evaluation of the organizational regulatory affairs program. Provides strategic and operational direction to ensure the organization is well-prepared for all regulatory surveys and meets all regulatory agency reporting requirements. Directs and oversees any on-site TJC accreditation, verification or complaint survey process. This individual will also be responsible for oversight and completion of all CMS and/or District of Columbia Department of Health licensure, validation or complaint survey requirements and management of the surveys for the Hospital and the Renaissance skilled nursing facility. The Director of Regulatory Affairs also guides and assists with the coordination of TJC certification surveys for specialty programs, such as the Stroke Certification or Total Joint Certification Programs. In addition, the incumbent would be available to offer support and guidance during regulatory surveys for individual hospital services, such as the Laboratory, Blood Bank, Imaging Services, Risk Management, and Patient Care Services.  In addition, the Director assists with regulatory affairs for the Renaissance, Skilled Nursing Facility (SNF) and Assisted living. Education: Bachelor’s Degree required. Graduation from an accredited school of nursing, public health or related clinical discipline preferred. Master's Degree in Nursing, Healthcare Administration or related field preferred.   Work Experience: Minimum of 5 years healthcare related experience (experience in regulatory compliance, performance improvement, quality improvement, patient safety or project management preferred).
  • Amherst, Massachusetts, The Export Control Compliance Specialist, under the direction of the Sr. Associate Director, Research Compliance, works to implement UMass Amherst’s export control compliance program. The Export Control Compliance Specialist will analyze research projects and activities for potential intersection with U.S. export control laws and regulations (“export controls”), determine if export controls apply, and initiate appropriate action to ensure compliance. The Specialist also provides export control training to campus community members, including faculty, staff, administration, and students.    Essential Functions Analyze, interpret, and apply U.S. export controls laws and regulations, including, but not limited to, the Export Administration Regulations (“EAR,” 15 CFR Parts 730-774), International Traffic in Arms Regulations (“ITAR,” 22 CFR Parts 120-130), and sanctions programs implemented by the U.S. Treasury Department, Office of Foreign Assets Control (“OFAC”), in a university setting. Review and analyze contractual and other documents related to proposing and conducting university research to identify intersections with export controls and, when applicable, develop, implement, and document the appropriate compliance response. Coordinate and communicate with researchers to obtain information necessary to determine whether export controls apply to their research projects and convey the results of export-control compliance analyses. Conduct restricted-party screening of research collaborators and other parties, including, but not limited to, sponsors, coresearchers, primary and subcontractors, and material providers and recipients, to determine potential inclusion on restricted entity/person lists issued by governmental departments and agencies. Analyze research subject matter to determine potential inclusion on lists of export-controlled items, such as the Commerce Control List (“CCL”) and U.S. Munitions List (“USML”). Identify and apply for license and commodity jurisdiction requests to Government entities. Develop and provide export control training to campus community members, including faculty, administrators, students, and other researchers. Attend export control training sessions conducted by Government departments and agencies, including, among others, Departments of Treasury, Commerce, and State. Minimum Qualifications (Knowledge, Skills, Abilities, Education, Experience, Certifications, Licensure) Bachelor’s degree in Legal studies, Public Administration, Business, Science or engineering, or other related field and two years demonstrated experience implementing and/or enforcing federal or state regulations, preferably in the area of export controls, trade compliance, or sanctions and embargoes, though other regulatory experience may be acceptable. An equivalent combination of education, training, and experience may be substituted. Strong interpersonal and communication skills; ability to interact with a diverse client base, both in writing and orally, including students, staff, faculty and campus and system leadership; ability to deal diplomatically with people at all levels. Excellent written and oral presentation skills, including ability to create compelling presentation materials and give effective presentations. Ability to analyze complex documents and situations, identify workable solutions, and effectively balance service with regulatory compliance. Intermediate level of experience with Microsoft Word, Excel and PowerPoint. Well-developed organizational skills; ability to independently work on multiple projects concurrently and prioritize those projects. Ability to work effectively and be flexible in a fast-paced, high-volume professional environment.
  • Newport News, Virginia, Dilon Technologies® is headquartered in Newport News, Virginia and is searching for a Director of Regulatory Affairs/Quality Assurance, Clinical; this is a key leadership role within the Company.  We strive to improve the quality of life by providing a wide range of innovative medical solutions that benefit patients around the world. Dilon has a strong medical device portfolio; the Navigator System, a trusted brand and world-renowned surgical gamma probe for radio-guided lymphatic mapping and tumor localization, the MarginProbe, a ground breaking technology for accurate margin assessment in breast cancer surgery, and the CoPilot, an innovative, portable, and easy to use video laryngoscope.   IN ORDER TO BE CONSIDERED FOR THIS POSITION, THE FOLLOWING BASIC QUALIFICATIONS MUST BE EVIDENT ON YOUR RESUME   Bachelor’s degree with 7 years of regulatory experience or Master’s degree with 5 years of regulatory experience  Experience in healthcare industry (i.e. medical device, pharma/drugs, biologics, biotech)  Experience in regulatory submissions (i.e. writing/developing/preparing/creating submission for Premarket Approval (PMA) for Class III medical devices, Investigational Device Exemption (IDE), EU technical files for Class IIa/IIb and design dossiers for Class III, clinical trials) Experience as a Management Representative leading a QMS  Nice to Have: Master’s Degree or Doctorate in Regulatory Affairs, Engineering, Quality or related technical field Expertise in IDEs, PMAs, 510(k)s, 180 Days, Design Dossiers, Technical Files,30 day Notices, and Real Time Reviews Experience with regulatory support of clinical trials Technically savvy; must be able to discuss, understand and make decisions regarding a wide array of engineering disciplines and complex technical/logistical issues Experience in assembling facts from various areas, analyzing data, and providing informed recommendations  Product experience with Radio Frequency (RF), Electromagnetic Compatibility (EMC), Software and Implantable devices and thorough knowledge of regulatory requirements Good working knowledge of FDA and international regulatory agency requirements, ISO/GHTF standards Regulatory Affairs Certification (RAC) Able to assess changes to design, process, labeling, packaging, sterilization and software to products in the market and under development for Regulatory reporting Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations. Ability to compile data and summarize results Organized, efficient, process-oriented; high attention to detail Effective interpersonal/communication skills Works well under pressure in a dynamic timeline-driven environment Ability to effectively manage multiple projects and priorities Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills  General Responsibilities: Preparation and maintenance of regulatory submissions and registrations of devices in the US (FDA) and Canada (Health Canada) Preparation and submittal of periodic reports for Class III devices in the US Preparation and maintenance annual renewals of Establishment Registrations, Device Listing, and other pertinent regulatory licenses Review of customer complaints to determine regulatory reportability requirements; in collaboration with the Senior Quality Technician, preparation/submittal of regulatory reportable events Actively participate in the evaluation of changes to the QMS documents and device design/process for impact on pending or existing registrations Review complex reports, validations, etc. for scientific merit and regulatory appropriateness Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation; advise project teams on premarket regulatory requirements, labeling requirements and/or clinical study compliance issues Monitor and advise the Senior Quality Technician of upcoming or new guidance, regulations, agency/industry initiatives, etc. to ensure regulatory strategies are in alignment with company objectives Interpretation of regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures Participate in compliance activities that relate to the department and the company, when needed Work closely with various teams (i. e. Regulatory Affairs, R&D, Quality, Manufacturing and Marketing) located at HQ and ROW Apply business and RA ethical standards Perform due diligence; Assess and interpret regulatory requirements and their impact Work with cross-functional international teams Paid vacation; 401(k); Short and Long-term Disability; Eligibility for health, vision, and dental insurance.