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