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Regulatory Compliance Specialist

4 months ago

Rancho Cordova, United States Life-Assist, Inc. Full time
Job DescriptionJob Description

Our Mission:

Together through a culture of caring and genuine connections, we help heroes save lives. Operating since 1977, Life-Assist, Inc. is one of the nation's largest distributors of emergency medical supplies and equipment for the First Responder, Paramedic, EMT and EMS Provider.

About This Opportunity

The Regulatory Compliance Specialist is responsible for ensuring Life-Assist meets, secures, and maintains necessary licensing in compliance with federal and state regulations. The Regulatory Compliance Specialist further supports obtaining certifications, customer license review, correspondence with regulatory agencies, adverse event reporting and product recalls.

Are you looking for an opportunity to join a company where employees love coming to work and helping heroes save lives every day? Do you enjoy working in a fast-paced, ever-growing environment? If this sounds like your job, we will enjoy hearing from you.

Some of the Things You Will Do

  • Serves as primary contact and representative for all interactions with state and federal regulatory agencies.
  • Respond to inquiries from federal and state authorities regarding customer activity up to and including subpoenas when applicable.
  • Represent the company in audits and inspections.
  • Interpret and apply FDA and other state and federal regulations to business practices and provides regulatory input, advice, and guidance to the organization.
  • Identify legal and regulatory changes that impact the business and recommends protocol enhancements to ensure company compliance.
  • Manage the preparation and submission of facility pharmacy license applications and renewals
  • Manage Pharmacy Board Designated Representative License applications and renewals
  • Review new customer accounts to maintain accuracy of prescription authorizations
  • Review customer Medical Director records to ensure data is current and licenses are not expired
  • Obtain renewed documentation for expiring medical licenses, to include medical director licenses, DEA licenses and Prescription Authorization Forms
  • Conduct monthly review of all facility and customer licenses to ensure Company is in full compliance with State and Federal regulations
  • Coordinate with the department managers an annual review to update the Company’s Policies and Procedures relating to medical device and/or pharmaceutical regulations
  • Update the FDA Wholesale Distributor License Reporting portal with current state license data periodically

Education and Experience:

  • Bachelor’s degree in business, or related discipline.
  • Ability to obtain a CA Pharmacy Board Designated Representative License.
  • Three to five years’ business experience in an administrative role related to Regulatory and Compliance.
  • Wholesale distributor licensing or other regulatory experience a plus.
  • Knowledge of regulations pertaining to the medical device and pharmaceutical industry a plus.
  • Experience working with regulatory authorities such as FDA, VAWD and State Board of Pharmacies a plus.

Knowledge, Skills and Abilities

  • Willingness to learn applicable FDA rules and regulations
  • Demonstrates sound business and professional ethics; protects confidential information
  • Ability to collaborate cross-functionally
  • Strong analytical, research and problem-solving skills
  • Outstanding communication skills, both written and verbal
  • Strong attention to detail and accuracy
  • Able to organize and prioritize tasks
  • Strong interpersonal skills and the ability to resolve conflicting interests and obtain cooperation
  • Demonstrated ability to work effectively with people at all levels within the company as well as with manufacturers, customers and regulatory agencies
  • Intermediate to advanced level of proficiency in MS Outlook, Word and Excel
  • Able to define problems, collect data, establish facts and draw valid conclusions
  • Goal-centered motivation; results-driven
  • Desire to belong to a team and contribute to the success of the larger organization

Benefits

We believe in showing employees how valuable they are to Life-Assist. Check out what you can expect when you join our team:

  • 15 accrued days Paid Time Off
  • 7 Paid Holidays, 2 paid floating holidays to use as you please, Spot Bonuses, Longevity Awards
  • Medical, Dental, Vision, Life Insurance, Short-term and Long-term disability pay and EAP
  • 401K Retirement Savings Plan with a match
  • Tuition Reimbursement

And much, much more…….

Submit your resume today for immediate consideration. Be sure to provide us with a response to our two questions

Life-Assist, Inc. provides a competitive salary, and a full benefits package to include medical, dental, vision, life, and retirement plan participation.

Life-Assist, Inc. promotes a drug-free workplace, and participates in the E-Verify Program. M/F/V/D

Life-Assist’s policy is to provide equal opportunity to all persons without regard to race, color, sex, gender identity, sexual orientation, religion, national origin, age, disability, Protected Veteran Status (Recently Separated, Disabled, Armed Forces Service Medal, Active Duty Wartime or Campaign Badge) or other bases protected by applicable law. Life-Assist prohibits harassment of applicants or employees related to these bases. We have established a continuing Affirmative Action Program to assure equal employment opportunity in all our policy decisions affecting recruitment, selection, assignment, promotion, training, and all other terms and conditions of employment.



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