The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requires working knowledge of products under review and of relevant regulations and guidance documents. This i

Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitor

The Compliance Manager works with the Director of Compliance and Chief Compliance Officer to support our Global business on compliance matters relating to adherence to relevant policies, codes, laws, and regulations impacting business operations. The Compliance Manager will assist with various aspects of our compliance program, including compliance training, auditing and

Collaborates in the development of communications strategies tailored for target audiences over multi channel platforms, and leads the execution of those efforts to inform, educate, and influence both internal and external audiences. Develops integrated communications strategies to reach key audiences, oversee implementation, and measure results. Develops message framewor

The FDA Center for Tobacco Products requires the assistance of minors ages 16 17 and those under age 18 20 to attempt the purchase of tobacco products from local tobacco retailers. The goal of the program is to ensure tobacco retailers are complying with Federal laws and regulations that prevent them from selling tobacco products to minors. This will be a part time, posit

Regulatory and Quality Assurance Specialist (Part time, 20 hrs/wk) Department Oticon Medical Other Job Locations US NJ Somerset Job ID 2024 21151 Overview This is a part time (20 hours/wk) position In this position you will be responsible for assuring quality and regulatory compliance including complaint handling for Oticon Medical LLC, as a US agent and initial importer

As the Manager of SOX Compliance working in the Global Accounting Organization, you will be responsible for leading the design, implementation and ongoing compliance with requirements under SOX and COSO standards. This includes SEC and statutory reporting, G/L and consolidations, revenue accounting, accounts receivable, accounts payable, payroll, tax, treasury and equity.

The Lead Analyst will provide support coordinating the operational Health Care Compliance (HCC) program elements for the Innovative Medicine North America (NA), and Global Functions (GF) organizations, including but not limited to the development and consistent administration of policies & procedures, training, communications, risk assessment, metrics reporting, transactio

FuturePlan is the nation's largest third party administrator (TPA) of retirement plans, partnering with advisors in all 50 states. FuturePlan delivers the best of both worlds high touch personalized service from local TPAs backed by the strength and security of a large national firm, Ascensus. Our roots go back decades, with nearly 30 outstanding legacy firms now joined t

R10037300 DOT Compliance Specialist (Open) Location Horsham, PA (Regional Office) Management How will you CONTRIBUTE and GROW? The Compliance Specialist DOT focuses on ensuring the Region's compliance with Department of Transportation (DOT), International Maritime Dangerous Goods (IMDG) code, and International Air Transport Association (IATA) regulations including driver c

We have an exciting career opportunity at the center of a rapidly growing global asset management firm. The Senior Compliance Manger will be part of the client solutions compliance team and will play an integral part of supporting client facing activities for the public markets business. At Macquarie, we are working to create lasting value for our communities, our clients

#LI OD1 #LI Onsite CBIZ.Jobs Category Benefits & Insurance REASONABLE ACCOMMODATION If you are a qualified individual with a disability you may request reasonable accommodation if you are unable or limited in your ability to use or access this site as a result of your disability. You can request a reasonable accommodation by calling 844 558 1414 (toll free) or send an ema

We have an exciting career opportunity at the center of a rapidly growing global asset management firm. The Senior Compliance Manger will be part of the Core Compliance team and will play an integral part of driving governance and implementing compliance frameworks. At Macquarie, we are working to create lasting value for our communities, our clients and our people. We ar

#LI OD1 #LI Onsite CBIZ.Jobs Category Benefits & Insurance REASONABLE ACCOMMODATION If you are a qualified individual with a disability you may request reasonable accommodation if you are unable or limited in your ability to use or access this site as a result of your disability. You can request a reasonable accommodation by calling 844 558 1414 (toll free) or send an ema

#LI OD1 #LI Onsite CBIZ.Jobs Category Benefits & Insurance REASONABLE ACCOMMODATION If you are a qualified individual with a disability you may request reasonable accommodation if you are unable or limited in your ability to use or access this site as a result of your disability. You can request a reasonable accommodation by calling 844 558 1414 (toll free) or send an ema