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Regulatory Compliance Manager

Company: Life-Assist Inc.
Location: Rancho Cordova
Posted on: May 11, 2022

Job Description:

Regulatory Compliance Manager 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. We show up every day, so we can "Help heroes save lives". Every decision we make and every action we take ensures that first responders can do their jobs as easily and effectively as possible. We count on them to count on us! We are seeking a highly motivated Regulatory Compliance Manager who thrives in a fast-paced environment, thinks outside the box and enjoys a teamwork environment. Add in a good amount of enthusiasm, positivity, and flexibility, and that describes a candidate we would like to meet. The Regulatory Compliance Manager is responsible for ensuring the Company maintains compliance with federal and state regulations related to pharmaceutical and medical device wholesale distribution and other areas as assigned. The Manager develops, implements, and audits compliance processes to ensure that operational procedures and conduct within the Company comply with applicable laws, regulations, and contractual agreements; establishes and sets the tone of compliance throughout the organization through interaction with employees, managers, executive management, and outside representatives. Who You Are Demonstrates sound business and professional ethics. Strong interpersonal skills and the ability to resolve conflicting interests and obtain cooperation. 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. Intermediate to advanced level of proficiency in MS Outlook, Word, and Excel. Education, Certification and Experience: Bachelor's degree in business or related discipline. (MBA, JD, or masters level education preferred) Five to seven years' experience in compliance, legal, or regulatory affairs. Ability to obtain a CA Pharmacy Board Designated Representative License. Pharmaceutical and or medical device wholesale distributor experience a plus. Knowledge of statutes and regulations related to drug and medical device distribution. (Food Drug and Cosmetic Act, DSCSA, Prescription Drug Marketing Act, 21 CFR, and state pharmacy laws). Knowledge of National Association Boards of Pharmacy and Drug Distributor Accreditation (formerly "VAWD"). Knowledge of regulations pertaining to the medical device and pharmaceutical industry a plus. Experience working with regulatory authorities such as FDA, NABP, and State Board of Pharmacies a plus. What You Will Do Ensure that daily operations and compliance programs comply with federal and state laws, regulations and Company policies and procedures. Interpret and apply regulatory requirements in the following areas: storage, handling, and distribution of pharmaceuticals and medical devices (temperature monitoring, receiving, storage, handling, suspect product, and DSCSA Track and Trace), customer and vendor licensing and verification, quality assurance, product recalls, and product complaints. Draft, review, and implement Company Policies and Procedures and other compliance related documents. Collaborate with Operations leadership on activities related to facility compliance processes and controls. Identify and respond to legal and regulatory changes that impact the Company. Review federal, state, and applicable trade websites and periodicals for updates. Maintain and obtain licensures within various states regulatory entities. Work to obtain and maintain company licensure with numerous states regulatory entities. Able to identify and monitor regulatory changes in a timely manner so that company leadership can be informed and take the actions necessary for the company to maintain If this position sounds like a good fit and you are interested in working for a company where employees love coming to work and helping heroes save lives every day, please submit your resume, and provide your answer to the following question: Describe how your experience makes you a qualified candidate for this position? Be specific. Life-Assist, Inc. provides a competitive salary, and a full benefits package to include medical, dental, vision, life, and retirement plan participation. It is the policy of Life-Assist, Inc. to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information, or any other protected characteristic under applicable law. Life-Assist, Inc. promotes a drug-free workplace, and participates in the E-Verify Program. M/F/V/D Employment Type: Full Time Years Experience: 5 - 10 years Bonus/Commission: No

Keywords: Life-Assist Inc., Rancho Cordova , Regulatory Compliance Manager, Executive , Rancho Cordova, California

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