Senior Operational Compliance Specialist (Remote)

DivIHN (pronounced Divine) is a nationally-recognized Business Technology Solutions and Staffing services provider headquartered in Chicago. Since our formation in 2002, we have been trusted by Fortune 500 organizations to help them locate and hire best-in-class talent through our Award-winning Professional Workforce Solutions program.
Check out our careers page to see all of our job openings: http://divihn.com/careers/find-a-job/
One of our BEST F500 customers has engaged us to help them hire a Senior Operational Compliance Specialist (Remote) to be available to work out of their office in N/A, N/A; details can be found below.
6 Months
Please apply or call one of us to learn more
For further inquiries regarding the following opportunity, please contact one of our Talent Specialists
Meghna at 224 369 4230
Title: Senior Operational Compliance Specialist (Remote)
Duration: 6 months initial contract with the possibility of conversion
Location: Remote
Position Summary
Supports quality and operational activities, including projects to successfully meet department and corporate goals. Key contributor in support and collaboration for the following:
State, Federal, and international distribution and manufacturing licensing
FDA establishment licensing and device listings
Global site registrations
Audits State, FDA, Notified Body, global regulatory bodies
Lead compliance-related projects
Additional Responsibilities As Assigned
Works closely with multi-site global Quality, Commercial, Legal, Planning, Supply Chain, Logistics and Operations teams to ensure compliance with numerous state, federal and global regulatory agencies.
Functional Description
Work is primarily achieved by individual along with others, or through project teams, utilizing technical or subject-matter expertise to achieve results
Emphasizes in-depth technical / subject-matter knowledge, project management and influence skills
Is expected to communicate effectively both vertically and horizontally within the organization, with suppliers and with customers.
Is expected to have strong lateral leadership skills, and be able to influence decisions within all project teams they are part of
Essential Duties And Responsibilities
Researching and completion of state, Federal and international manufacturing and distribution licensing laws, rules, and statutes for applicability
Ability to lead complex projects through advanced project management skills
Support internal and external audit activities as assigned (fulfill audit requests, review records for accuracy, scribe, etc.)
Must have the ability to read and understand legal terminology, or the interest and capacity to learn
Must have a strong drive to develop partnerships throughout the organization to advance the departments influence and impact.
Must have innovative resolution skills in pursuit of continuous improvement efforts
Must be able to assess risk and deploy action appropriately, including the escalation of matters which warrant.
Must be able to independently manage their time and prioritize competing priorities to meet established deadlines
This job description reflects management's assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned.
About Us
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.