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Compliance Specialist

4 months ago

Rancho Cordova, United States LHH Full time

LHH is seeking a Regulatory Compliance Specialist for a client in Rancho Cordova. This is a Temp to hire opportunity. The Regulatory Compliance Specialist is responsible for ensuring the Company meets, secures, and maintains necessary licensing in compliance with federal and state regulations. This role supports obtaining certifications, customer license review, correspondence with regulatory agencies, adverse event reporting, and product recalls.

Daily and Periodic Operations:

  • Monitor the Compliance inbox.
  • Communicate with Customer Care to resolve questions regarding customer accounts.
  • 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, including medical director licenses, DEA licenses, and Prescription Authorization Forms.
  • Manage the preparation and submission of facility pharmacy license applications and renewals.
  • Manage Pharmacy Board Designated Representative License applications and renewals.
  • Conduct monthly reviews of all facility and customer licenses to ensure the Company is in full compliance with State and Federal regulations.
  • Coordinate with department managers an annual review to update the Companys Policies and Procedures relating to medical device and/or pharmaceutical regulations.
  • Maintain verification of employee training on Companys 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.
  • Support product recall procedures if needed.
  • Visually inspect facilities for compliance.
  • Serve as the primary contact and representative for all interactions with state and federal regulatory agencies.
  • Respond to inquiries from federal and state authorities regarding customer activity, including subpoenas when applicable.
  • Represent the company in audits and inspections.
  • Interpret and apply FDA and other state and federal regulations to business practices, providing regulatory input, advice, and guidance to the organization.
  • Collaborate with department managers to collect corporate and individual information of a confidential and sensitive nature as required for proper licensure.
  • Review federal and state agency websites and periodicals for applicable updates.
  • Identify legal and regulatory changes that impact the business and recommend protocol enhancements to ensure company compliance.

Knowledge, Skills & 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.
  • Ability 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 proficiency in MS Outlook, Word, and Excel.
  • Ability 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.

Education, Licenses & Experience:

  • Bachelors degree in business, or a 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 is a plus.
  • Knowledge of regulations pertaining to the medical device and pharmaceutical industry is a plus.
  • Experience working with regulatory authorities such as FDA, VAWD, and State Board of Pharmacies is a plus.

Pay rate is between $35hr to $40hr based on skills.