Regulatory Affairs Coordinator

7 days ago

Sacramento, California, United States LHH Recruitment Solutions Full time
Job DescriptionJob DescriptionRegulatory Affairs Coordinator (Sacramento, CA)

LHH is teaming up with an established client search of a Regulatory Affairs Coordinator

The Regulatory Affairs Coordinator will ensure the organization complies with federal and state regulations by securing and maintaining necessary licenses. They will support certification processes, review customer licenses, liaise with regulatory agencies, manage adverse event reporting, and handle product recalls.

The ideal candidate is a detail-oriented and ethical professional with a bachelor's degree in business or a related field and 3-5 years of experience in regulatory and compliance roles. They possess strong analytical, research, and problem-solving skills, along with excellent written and verbal communication abilities. Proficiency in MS Outlook, Word, and Excel, as well as the ability to collaborate effectively across departments and interact confidently with regulatory agencies, is essential. Familiarity with FDA regulations and experience with wholesale distributor licensing or other regulatory areas are highly beneficial.

Key Responsibilities:

Daily Operations:
  • Monitor compliance-related communications.
  • Coordinate with Customer Care team to resolve account queries.
  • Verify prescription authorization accuracy for new customer accounts.
  • Update Medical Director records and renew medical licenses, including DEA and Prescription Authorization Forms.
  • Prepare and submit applications and renewals for facility pharmacy and Board Designated Representative licenses.
  • Conduct monthly audits of facility and customer licenses for regulatory compliance.
  • Collaborate with department managers on annual updates to policies and procedures related to medical devices and pharmaceuticals.
  • Document employee training on company policies and procedures.
  • Periodically update the FDA Wholesale Distributor License Reporting portal with current license data.
  • Support product recall procedures as necessary.
  • Conduct visual compliance inspections within the facility.
  • Act as the primary contact for regulatory agency interactions.
  • Respond to regulatory inquiries, including subpoenas.
  • Represent the organization during audits and inspections.
  • Interpret and apply FDA and other regulatory standards to business operations, providing guidance to the organization.
  • Collect and handle confidential corporate and individual information for licensing purposes.
  • Monitor regulatory updates and identify changes impacting the business, recommending compliance protocol enhancements.

Required Knowledge, Skills, and Abilities:
  • Eagerness to learn FDA regulations.
  • Strong ethical standards and confidentiality.
  • Ability to collaborate across departments.
  • Excellent analytical, research, and problem-solving skills.
  • Superior written and verbal communication skills.
  • High attention to detail and accuracy.
  • Effective task organization and prioritization.
  • Strong interpersonal skills and conflict resolution abilities.
  • Proficiency in MS Outlook, Word, and Excel.
  • Ability to define problems, collect data, and draw valid conclusions.
  • Goal-oriented and results-driven.
  • Team-oriented mindset and commitment to organizational success.

Education, Licenses, and Experience:
  • Bachelor's degree in business or a related field.
  • Eligibility to obtain a CA Pharmacy Board Designated Representative License.
  • 3-5 years of administrative experience in regulatory and compliance roles.
  • Experience with wholesale distributor licensing or other regulatory areas is advantageous.
  • Familiarity with medical device and pharmaceutical regulations is beneficial.
  • Experience interacting with regulatory bodies like FDA, VAWD, and State Boards of Pharmacy is preferred.
Job Type: Temp-to-Hire

Location: Fully on-site in Sacramento, CA

Pay Rate: $35-$45/hour, depending on experience

Hours: Full time, regular office hours

Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria.

If you have the qualifications above and are interested in this opportunity – please apply today If you are curious what else is available, please review the LHH website

Pay Details: $35.00 to $45.00 per hour

Search managed by: Emily Sclar

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to

The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.

  • Sr. Regulatory Affairs Specialist

    3 weeks ago

    Sacramento, California, United States Inspire Medical Systems, Inc. Full time

    ABOUT INSPIRE MEDICAL SYSTEMS Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Our...

  • Sr. Regulatory Affairs Specialist

    4 weeks ago

    Sacramento, California, United States Inspire Medical Systems, Inc. Full time

    ABOUT INSPIRE MEDICAL SYSTEMS Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Our...

  • Sr. Regulatory Affairs Specialist

    6 days ago

    Sacramento, California, United States Inspire Medical Systems, Inc. Full time

    ABOUT INSPIRE MEDICAL SYSTEMS Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Our...

  • Regulatory Affairs Specialist II

    7 days ago

    Sacramento, California, United States Bausch + Lomb Full time

    Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world-from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better. Our comprehensive portfolio of over 400 products is fully...

  • Sr Regulatory Specialist

    4 days ago

    Sacramento, California, United States General Mills, Inc Full time

    Job Description Overview We are seeking someone with international regulatory experience to lead product compliance for our pet food business outside of North America. This individual will be responsible for providing market access and assuring compliance to federal regulation of country of sale, including Import regulation, labeling, product standards,...

  • Public Affairs Specialist

    1 month ago

    Sacramento, California, United States U.S. Fish And Wildlife Service Full time

    As a Public Affairs Specialist your duties will include, but are not limited to, the following:Serves as a senior Fish and Wildlife Service (FWS) spokesperson with reporters and the media on sensitive, complex, highly visible, and controversial matters, some of which may have international significance; and responds to inquiries for information and...

  • Program Technician Iii

    6 days ago

    Sacramento, California, United States Department of Consumer Affairs Full time

    The Board of Vocational Nursing and Psychiatric Technicians (BVNPT) is currently recruiting for a Intake and Enhanced Screening Unit Manager within the Enforcement Division's LACRU Unit. Under the general direction of Board of Vocational Nursing and Psychiatric Technicians (BVNPT) Program Tech III supervisor, the PT III position is responsible for...

  • Organ Procurement Coordinator

    7 days ago

    Sacramento, California, United States Stanford Health Care Full time

    1.0 FTE Full time Rotating - 08 Hour R Remote 78641 LIVER TRANSPLANT Business & Administration th St Room B-27,Sacramento,California If you're ready to be part of our legacy of hope and innovation, we encourage you to take the first step and explore our current job openings. Your best is waiting to be discovered.Rotating - 08 Hour (United States of...

  • Admissions Coordinator

    6 days ago

    Sacramento, California, United States Bruceville Terrace Full time

    OverviewResponsibilitiesJob Summary:The Admissions Coordinator performs activities and duties related to pre-admission evaluation and admission of patients to Bruceville Terrace. The goal of the coordinator in this role is to identify patients who meet criteria and who are appropriate for admission to Bruceville Terrace. Included in this role is the ability...

  • public utilities regulatory analyst i

    7 days ago

    Sacramento, California, United States State of California Full time

    Job Posting: Energy Cost Analyst Public Utilities Commission JC Energy Cost Analyst PUBLIC UTILITIES REGULATORY ANALYST I $4, $7,119.00 per Month Final Filing Date: 5/24/2024 Application Methods: Electronic (Using your CalCareer Account) By Mail Drop-off Job Description and Duties Individuals interested in applying for this vacancy must have...

  • Director - Pharmacy Compliance & Diversion Control

    3 weeks ago

    Sacramento, California, United States Cencora Full time

    Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals...

  • Admissions Coordinator

    3 weeks ago

    Sacramento, California, United States Dignity Health Full time

    OverviewBruceville Terrace has been providing quality compassionate care since 1989. Licensed as the 171-bed sub-acute skilled nursing facility of Methodist Hospital of Sacramento Bruceville Terrace offers care for the elderly as well as those requiring extended recoveries.Bruceville Terrace provides skilled nursing rehabilitative and complex medical...

  • Admissions Coordinator

    1 month ago

    Sacramento, California, United States Dignity Health Full time

    OverviewBruceville Terrace has been providing quality compassionate care since 1989. Licensed as the 171-bed sub-acute skilled nursing facility of Methodist Hospital of Sacramento Bruceville Terrace offers care for the elderly as well as those requiring extended recoveries.Bruceville Terrace provides skilled nursing rehabilitative and complex medical...

  • FDC Quality Management Technician

    3 weeks ago

    Sacramento, California, United States Target Full time

    The pay range per hour is $ $35.29Pay is based on several factors which vary based on position.These include labor markets and in some instancesmay include education, work experience and certifications. In addition to your pay, Target cares about and invests in you as a team member, so that you can take care of yourself and your family. Target offers...

  • Community Outreach Coordinator

    7 days ago

    Sacramento, California, United States Sacramento LGBT Community Center Full time

    REPORTS TO:|Communications & Marketing Manager---|---STATUS:|Full-timeCOMPENSATION:|$21-23 per hourBENEFITS:|Medical, Dental, Vision, and Life Insurance; Employee Assistance Program; 403(b) Retirement Plan; Paid Holidays, Sick, and VacationLOCATION:|(Multiple) Sacramento, Placer, El Dorado, & Yolo countiesJOB SUMMARY:The Community Outreach Coordinator plays...

  • Senior Government Relations Representative

    6 days ago

    Sacramento, California, United States Pacific Gas And Electric Company Full time

    Requisition ID# 157573Job Category: Government and Regulatory RelationsJob Level: Individual ContributorBusiness Unit: Corporate AffairsWork Type: HybridJob Location: SacramentoDepartment OverviewPG&E's Local Government Affairs team leads the Company's government relations activities and strategies in the cities and counties we serve, helping to shape...

  • Clinical Research Coordinator

    7 days ago

    Sacramento, California, United States Medix™ Full time

    We are looking for an experienced CRC to join a multi-site organization in Sacramento, CA. This is a great opportunity to set your roots down with a growing team that offers great benefits and provides a welcoming environment that fosters growth. Apply todayDuties:Facilitates and coordinates the daily clinical trial activities and plays a critical role in...

  • Specialty Healthcare Coordinator

    14 hours ago

    Sacramento, California, United States tapwage Full time

    Now is the time to join Strawberry Creek Dental Group. You will have opportunities to learn new skills from our team of experienced professionals. If you're ready to take your career to the next level and gain valuable experience, apply todayThe primary role of the Specialty Healthcare Coordinator (SHC) is to partner with supported Specialists to help gain a...

  • Senior Clinical Research Coordinator/CRC

    6 days ago

    Sacramento, California, United States UC Davis Health Full time

    Job Summary The Clinical Research Coordinator is a health professional having working knowledge of clinical research activities, communication skills and a willingness to cooperate as a team member. Required is the use of skills to independently or with general direction coordinate and follow through in the overall administration and outcome of clinical...

  • Rehabilitation Services Coordinator

    4 weeks ago

    Sacramento, California, United States Allina Health Full time

    Number of Job Openings Available:1Date Posted:May 16, 2024Department: Courage Kenny Rehabilitation Institute Therapy Staff ResourcesShift:Day/Evening (United States of America)Shift Length:8 hour shiftHours Per Week:40Union Contract:Non-UnionWeekend Rotation: NoneJob Summary:The Rehabilitation Services Coordinator is the first point of contact for patients...