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WELCOME

As the chair of the RAPS Twin Cities 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 Twin Cities 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,

Lena Cordie
Chair, Twin Cities 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

  • 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.
  • Richmond, Virginia, Have 10 years of leadership experience in quality systems and operations with the FDA or in an FDA regulated environment? Have a passion for driving excellence and compliance in everything you do? If so, we want to speak with you!  We are currently seeking a  Manager, Regulatory Quality Compliance  to join our Regulatory Quality Audits & Requirements department in  Richmond, VA. This role will work with multiple business partners to prepare for FDA Tobacco Product Manufacturing Practice (TPMP)’s. You will collaborate with quality, manufacturing, and product development personnel to evaluate their quality systems and product processes. In this role, you will: • Generate TPMP gap assessments of existing processes and systems against Altria Quality Requirements (AQR) using multi-disciplined, multi-functional teams. Plan and conduct research on good manufacturing, good laboratory, good clinical practices, and product development requirements pertinent to FDA regulated industries to support the development of Altria Quality Requirements (AQR), Quality Management System (QMS) and general quality practices • Lead enterprise FDA Inspection Readiness Plans to support TPMP readiness activities. Develop proficiency in industry proposed TPMPs. Generate and lead project plans to address remediation plans. Generate metrics to track project progress • Develop, lead, and write position papers which define the rationale for TPMP response and interpretation • Conduct trend analysis and formulate management communications for emerging quality risks related to TPMPs • Craft and improve quality requirements and standards through independent research and interpretation of other FDA regulated industries and standards • Provide mentorship and recommendations to management on tobacco Manufacturing Practices (TPMP) implementation and issues resolution • Lead Quality Compliance activities with respect to TPMP readiness • Participate and/or lead QMS audits • Provide TPMP Quality Compliance support for Vendor and Supplier Management, including, but not limited to, Contract Manufacturing Organizations, Contract Labs, Quality Agreements, QMS infrastructure, and risk management • Advise on internal and external situations which may pose quality/compliance risks that may adversely affect business operations • Conduct analyses, consulting and assessments of various operations and processes by applying their knowledge and judgment in areas where they may have little to no previous work experience • Lead or participate in corrective actions and programs designated to improve the quality and compliance posture of the organization • Maintain confidentiality of information acquired during audits We want you to have: • Bachelor's degree in a Physical Science, Engineering or related field • Minimum of 10 years of leadership experience in FDA and or FDA regulated quality systems and operations (pharmaceuticals, medical devices, and dietary supplements). Experience in product development preferred. • Working knowledge of Data Integrity and product development related requirements. • Strong analytical and organizational skills • Strong written, verbal and presentation skills along with proven ability to collaborate with others • Ability to considerately, independently and persuasively provide critical and sensitive feedback to the most senior levels of management • Proficiency in conflict negotiation and resolution is preferred • Perform assignments in an independent and autonomous manner with minimal direct supervision • Able to utilize various computer software to include: Word, Excel, PowerPoint, and Outlook • Comfortable working during non-core hours as required to assess multiple shifts and operations spanning lengthy periods At Altria Client Services, we recognize that our people are the reason we achieve our business goals. We believe in developing the leadership potential of our employees by providing them with opportunities for training, development, and advancement.
  • Raleigh, North Carolina, Director of Research Compliance - 00100185 NC State University Office of Research and Innovation (ORI) Sponsored Programs and Regulatory Compliance Services (SPARCS) Raleigh, NC   Position number: PG190572EP,   Position Description: The Director will provide leadership through oversight of and guidance to faculty and administrators in the areas of Conflict of Interest and Commitment, Notice of Intent, Institutional Animal Care, Institutional Review Board, Research Integrity, Export Controls and National Security, and provide oversight of the entire compliance enterprise within Research Administration. The individual in this position will serve as the responsible institutional official for human subject research, animal subject research, as well as serve as the Research Integrity Officer and empowered official for export controls. The Director will report to the Assistant Vice Chancellor for Finance and Administration within the Office of Research and Innovation.   Responsibilities include but are not necessarily limited to the following: 1. Serve as Export Controls and National Security Officer: a. Implement policies and procedures developed in coordination with other compliance stakeholders on campus b. Serve as a point of contact for export control and national security issues from all constituents, particularly: i. Travel Audit ii. Sponsored Programs iii. Environmental Health iv. Purchasing v. Provost Office c. Assess, on a continuing basis, the institution’s ability to receive and manage confidential, proprietary, classified or other information contractually obligated as secret. Develop and deploy procedures, training and awareness efforts to ensure faculty and staff are prepared and capable to handle such information. 2. Serve as a Research Integrity Officer: a. Receive and vet new allegations of misconduct (falsification, plagiarism or fabrication) brought forth pursuant to pertinent regulation; b. Identify inquiry and investigation committee membership and coordinate all meetings as needed; c. Perform all directed inquiry and investigative steps under the direction of appointed committees; d. Guide inquiry and investigation committees in the proper conduct of an inquiry and/or investigation and assist in the development of inquiry and investigation reports compliant with NC State regulation and external oversight body expectation (ORI, OIG, etc.) e. Work with the Graduate School and others in developing, coordinating and delivering training materials and symposia on integrity in science and scholarship. 3. Serve as Conflicts of Interest and Commitment Officer: a. Guide and counsel faculty, department heads and deans on the development of Conflict of Interest and Commitment management plans to ensure unencumbered objectivity in carrying forth institutional duties when an employee has a significant financial interest or other conflict covered by pertinent regulation; b. Serve as ex-officio member of all Conflict of Interest and Commitment Oversight Committees and, working with the committee chair, steward the institutional charge to that committee; c. Perform investigative work directed by the Committee as necessary. 4. Serve as Facilities Security Officer (FSO) for Classified Research. Reporting directly to the Chancellor, the FSO will: a. Develop and manage a compliance program consistent with the National Industrial Security Program (NISP). http://www.dss.mil/isp/fac_clear/download_nispom.html b. Liaison with federal and industrial sponsors regarding funding arrangements for classified research. c. Resource the industrial security program making recommendations to senior management (the AVC, VC, and C) on fiscal and human resource needs to affect and maintain a robust security program d. Remaining duties are articulated in the National Industrial Security Operating Manual (NISPOM) and include, need-to-know determinations, physical security reviews, coordination with Defense Security Service (DSS), Federal Bureau of Investigation (FBI), Naval Criminal Investigative Services (NCIS), and sensitive sponsored operations of the defense and civilian intelligence services. 5. Oversee the entire research regulatory compliance mission of the institution (human subjects, animal subjects, etc.).   Interested in applying? All applications must be submitted online through the NC State employment website. To view the full job posting, application instructions, and to submit an application please visit: https://jobs.ncsu.edu/postings/134514     Inquiries and nominations are invited and may be directed to NC State Executive Search Services at executivesearch@ncsu.edu   NC State University is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, gender identity, age, sexual orientation, genetic information, status as an individual with a disability, or status as a protected veteran.