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WELCOME

Thank you for visiting the RAPS Utah Chapter! On behalf of the leadership team, welcome! We are glad you are here.

Before we were a full Chapter, the Utah Local Networking Group already had 450 participants! Does this surprise you? It does not surprise us. Sometimes referred to as “silicon slopes,” Utah is home to over 265 life sciences and related companies, many research organizations, consultants, and countless start-ups growing out of our thriving universities and venture capital initiatives.

So why should you join? Because activity at the local level is integral to the RAPS mission. Here is where the networking, the shared experiences, the seminars, the relationships happen. Get to know regulatory professionals in your area, and share your knowledge base, learning from theirs. Together, we will all be more successful.

I encourage you to subscribe to our message board and check back regularly to see what activities we have planned. We have many opportunities to get involved in our leadership team. Partnering with related trade organizations, we already have many professional seminars and other activities planned. We need your help! The more regulatory expertise we have supporting our efforts, the more successful they will be.

Thanks again for visiting our page! I look forward to seeing you soon at a RAPS Utah event!

Warm regards,
Robert M. Wolfarth
Chairman, RAPS Utah Chapter

P.S: Although our Chapter is based in the Salt Lake City area, we welcome members from all over the Rocky Mountain region to our professional and social functions, and participation and membership from RAPS professionals worldwide. From Missoula to Tucson, we share a common purpose to promote the industry in our region. 

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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

  • San Fernando, California, Pharmavite, LLC has an oppty in San Fernando, CA for a Quality Contrl Supvr. Mail resume to Attn: HR, 8531 Fallbrook Ave, West Hills, CA 91304; Ref #SFNMI. Must be legally auth to work in the US w/o spnsrshp. EOE
  • Santa Clara, California, The Senior Manager, Regulatory Affairs works closely and partners with internal departments and department management to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Senior Manager, Regulatory Affairs combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements. In alignment with responsible Regulatory Affairs management, functions independently as a decision-maker on regulatory issues, assures that submission/registration/renewal deadlines are met, and supports new product development. Effectively communicates, prepares, and negotiates both internally and externally with various regulatory agencies. The Senior Manager, Regulatory Affairs properly interprets and applies regulatory requirements and is recognized as a discipline expert and resource in Regulatory Affairs. Essential Job Functions Collaboratively interface with a variety of levels on significant matters, frequently leading the coordination of activity across organizational units Manage, mentor, and develop direct reports to meet individual and company goals and objectives Develop, follow, and train key personnel on regulatory policies, processes and SOPs Develop and implement regulatory strategies and update strategy based upon regulatory changes Determine submission and approval requirements in assigned geographies and establish work plans/delegate assignments to team in order to effectively meet the requirements Provide strategic input and technical guidance on regulatory requirements to Regulatory, product development and operations teams Work with product development, quality and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, REACH, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents) Effectively and accurately write and edit technical documents Review and approve R&D, quality, preclinical and clinical documentation for submission filing Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements Provide guidance to functional groups in the development of relevant data to complete a regulatory submission In collaboration with cross-functional team members, compile, prepare, review and submit regulatory submissions to authorities in and outside the US (e.g., EU, Canada, Australia, Japan, etc.) Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvals Effectively communicate application progress to internal stakeholders Effectively communicate, prepare, and negotiate both internally with cross-functional teams and externally with various regulatory agencies. Direct the process for preparation and maintaining annual licenses, registrations/listings for assigned geographies Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation Provide regulatory input for product recalls and recall communications In collaboration with Regulatory management, develop, communicate, and build consensus for regulatory goals that are in alignment with the company goals and objectives Review and approve advertising and promotional materials to ensure regulatory compliance Evaluate, provide guidance and implement import/export requirements Identify emerging issues and regularly communicate status Provide other country specific regulatory support Plan and conduct meetings, create project plans and timelines, and manage projects Exercise good and ethical judgment within policies and regulations Perform multiple tasks concurrently with accuracy Other duties as assigned Requirements Bachelor's degree in science, math, engineering, or medical fields is preferred.  Post-graduate degree in a technical area, M.B.A. or law is preferred Minimum 12 years’ experience in a regulated healthcare industry. Class III medical device experience preferred Minimum 2 years’ prior management and positive mentorship experience is preferred Medical device software engineering background or experience is preferred. Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations Strong knowledge of and experience with pre- and post-market medical device regulations, requirements and submissions, such as 510(k), IDE, PMA, EU Technical Files, Design Dossiers, etc. Ability to outline sound regulatory strategy in alignment with regulations and business priorities Think analytically with excellent problem-solving skills Effectively negotiate internally and externally with regulatory agencies Clear and effective verbal and written communication skills with diverse audiences and personnel Knowledge of business functions and cross group dependencies/ relationships. Strong organization and time management skills, including the ability to prioritize multiple challenging project timelines in a fast-paced environment while ensuring collaboration, accuracy of submissions, and all deadlines are met Leadership of functional groups in the development of relevant data to complete a regulatory submission Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues Able to effectively and positively lead direct reports while demonstrating flexibility to changing environments. Proficient in MS Word, Excel, Adobe and Power Point
  • Salinas, California, INSPIRING HEALTHY LIVES through community At Natividad, our dedication to the people of Monterey County is at the heart of everything we do—from the health care services we provide to the specialized programs we promote. This commitment to our community spans more than 130 years and, more importantly, has touched countless lives. It has also earned us a Joint Commission ranking in the top percentile of hospitals nationwide. If you believe in inspiring healthy lives by focusing on community-based care, consider joining Natividad today. HOSPITAL QUALITY ASSURANCE NURSE Natividad is currently seeking a permanent, full-time Hospital Quality Assurance Nurse to assist in the design, facilitation and coordination of quality assurance and performance improvement activities and to work collaboratively with the Natividad medical staff, hospital departments and clinics as part of an effective quality assurance program. We rely on this position to assist in the development and implementation of policies and procedures, review and evaluate patients' medical records, conduct incident investigations and analyze/validate clinical data. This position will also be expected to perform Core Measure abstractions and data analysis.     Minimum qualifications include a CA RN license or the ability to obtain a CA RN license prior to employment and knowledge of current theory, principles, techniques and procedures used in professional nursing, including those applicable to an acute care hospital and practices of medical quality assurance. For more information or to request application materials, contact Natividad, Human Resources Department, 1441 Constitution Blvd., Salinas, CA 93906, (831) 783-2700, or apply at http://www.natividad.com . Like us on Facebook: https://www.facebook.com/NatividadInspiringHealthyLives/   EOE/M/F/H/V