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WELCOME

As the chair of the RAPS San Francisco 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, you also have access to a vibrant regulatory community right here in the Bay Area.

The RAPS San Francisco Chapter conducts professional development and networking activities throughout the year to help members connect, build relationships and increase their knowledge. RAPS is a volunteer-driven organization. I’ve benefited in so many ways by getting involved in helping our chapter. There are a number of volunteer opportunities available at the chapter and national levels. I am happy to help you identify a way that you can contribute your time 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 discussion board. Members residing outside of this chapter’s region can find and join a chapter's online community from the chapter community listing.

I 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 how I can be of assistance.

Sincerely,

Susan Carino, RAC
Chair, San Francisco 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

  • 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
  • Mankato, Minnesota, The administrator occupies a unique leadership role within the organization. One of the successes of Mayo has been the collegiality and mutual support demonstrated by physician and administrative leadership. This partnership brings together the clinical and managerial talents necessary to achieve the Mayo Clinic strategic and operating plan. The administrative and physician leadership roles cannot be separated. The purpose of the partnership is: * To translate the institutional vision to meaningful and effective operational responses * To bring an institutional perspective to daily decisions and to bring an operational perspective and experience back to the institution * To see, initiate and organize opportunities to improve service and quality and to act as a catalyst for realizing these improvements * To act as a facilitator, champion and generator of new ideas and a mediator on difficult issues * To bring awareness of current external issues such as reimbursement, legislative, alternative delivery modes, etc. * To assist physician and allied health staff in developing leadership, managerial skills and succession planning * To have adequate knowledge and perspective of Mayo Clinic and business operations to know when and where to acquire additional input and expertise * To provide financial oversight of department. The administrator may provide direct patient care, contingent upon maintaining appropriate licensure and competencies. Experience: Required: A minimum of 5 years healthcare management experience with clinical and administrative responsibilities, including strategic planning, marketing, budgeting, customer service and performance improvement Preferred: Strong leadership, team building, and problem-solving skills as well as demonstrated ability to work collaboratively with multiple disciplines, i.e., physician, administrative, supervisory and allied health staff. Incumbents maybe expected to rotate through a variety of clinical department or division assignments with the duration of the rotation usually being 3-6 years. Education: Required: Master's degree in business or healthcare field. Special Skills: Required: Demonstrated leadership, team building and problem solving skills as well as demonstrated ability to work collaboratively with multiple disciplines i.e. physician, administrative, supervisory and allied health staff. Must have demonstrated competencies in leadership, management, operations, quality and communication. Broad based upper management experience is required in order to coordinate a wide range of activities in both clinic and hospital settings. Mankato is one of the largest cities in southern MN and has earned several livability awards. Mankato's economic growth leads Minnesota and is among the top in the nation. The city has a contiguous population area of 96,740 and 1.6 million people live within 60 miles of Mankato. Greater Mankato is centrally located in south central Minnesota, nestled in the scenic beauty of the Minnesota River Valley, with convenient access to Minneapolis-St. Paul just one hour away.
  • St Louis, Missouri,   It's more than a career, it's a calling SSM Health Cardinal Glennon Children’s Hospital  is a non-profit 195-bed inpatient and outpatient pediatric medical center in  St. Louis, Missouri . As the nation’s only free-standing, Catholic children’s hospital, SSM Health Cardinal Glennon has provided care for children regardless of ability to pay since 1956. SSM Health Cardinal Glennon primarily serves children from eastern Missouri and southern Illinois, but also treats children across the United States and from countries around the world. SM Health Cardinal Glennon also serves as a teaching hospital affiliated with the neighboring  Saint Louis University  Schools of Medicine and Nursing, and nine other education institutes. Coordinate and manage the BMT/Car-T Quality Program. This position will consist of jobs including, but not limited to record review, ensuring policies and procedures within the program are monitored and updated to meet standards, perform risk assessments and aide in event investigation, development of action plans and monitoring compliance, and overall, ongoing program compliance. Provides support for the business objectives to support program(s) of a defined area. PRIMARY RESPONSIBILITIES Collaborates to identify program opportunities and recommends business plan and budget. Promotes the program and referral sources for targeted customers. Builds relationships within discipline to develop business. Collaborates in the development of marketing outreach activities and communication materials. Analyzes and recommends actions based on key program trends and milestones. Performs other duties as assigned. EDUCATION Graduate of accredited school of nursing EXPERIENCE Four years' registered nurse experience in related department or critical care role   EXPERIENCE Four years' registered nurse experience in related department or critical care role   RN Nursing License Required Competitive salary and benefit package