Assists with other regulatory documentation as required by FDA and individual countries. Prepare global regulatory files/submissions for product registration as assigned. Assist in the review of proposed design changes and ECOs to assess regulatory impact. Assist the Specialists in assembly and upda...
Regulatory Strategy (Intermediate): Demonstrates ability to successfully prepare long-range plans for a major regulatory requirement. Initiates requests for data analytics to identify potential regulatory risks. Regulatory Documentation (Intermediate): Writes clear, concise and comprehensive documen...
Management of FDA, DEA and TSA regulatory requirements including hosting inspections as needed. Implement and maintain site SOPs that adhere to applicable regulatory requirements and Thermo Fisher policies as well as, developing/improving appropriate local processes, where needed. ...
Support cross-functional projects through the provision of regulatory submission/compliance strategy document, regulatory inputs, and documentation reviews (CER, IOVV, Risk Management Documentation, etc. Bachelor’s degree required in Life Sciences, Business Administration, Nursing or Medical Technol...
Corporate Experienced Tax Accountant - Nashville - Great Work Life Balance and Hybrid office schedule.Our client, located in Nashville , is looking to hire a Tax Senior Accountant to their team.The team has great tenure, flexibility, and work-life balance.This is a dynamic position with a variety...
As the Engineering Project Manager you will plan, direct, coordinate engineering for assigned design projects to ensure client goals or objectives are accomplished within prescribed time frame and funding parameters within nuclear operations and engineering. Everything we do is more than just a proj...
Establish, nurture, and grow direct customer relationships (owners, asset managers, property managers, facility managers, building engineers, roof consultants). We're looking for a Sales Project Manager who thrives on closing deals and loves the excitement of achieving big financial wins. Our ideal ...
The OSHA Compliance Specialist will provide OSHA services designed to assist and support client OSHA recordkeeping obligations, run QC/exception reports, and generate routine and ad hoc reports as requested and facilitate client compliance with regulatory requirements. Serves as subject matter exper...
The Program Manager will also maintain a manageable caseload initially until the need for a full time Program Manager is established. The Program Manager will be responsible for the operation of the community-based program. The Program Manager will have the responsibility and authority for all actio...
At least 10 - 15+ years' experience in pharmaceutical regulatory affairs with significant experience in global regulatory affairs activities. Provide regulatory affairs project management including timelines and tracking of ongoing regulatory activities and supporting departmental budgeting activiti...
Title: Coding Specialist - Compliance/Coding. ...
SLG 1st Line of Defense (LOD) Compliance Specialist is responsible for partnering with multiple areas of FirstBank, including Corporate Compliance and Risk Management, in addition to other 1st LOD Compliance Specialists and teams, in order to identify and mitigate regulatory compliance risk for the ...
Compliance Senior Analyst, Independence Consultation - Business Relationships, Independence & Conflicts Network (ICN). Do you have a focus on compliance with regulations and policies? Are you passionate about quality-assurance and risk-management in a professional services environment? Then our ...
JOB SUMMARY/ESSENTIAL JOB FUNCTIONS: The Institutional Review Board (IRB) Regulatory Specialist analyzes research protocol submissions to assure that protocol procedures and the consent process are structured in a manner that meets the requirements of federal, state, and institutional regulations an...
Responsible for completing the project as per its contracted scope; monitor progress and performance against the project plan. Conducts meetings and prepares reports to communicate the status of the project to project team and client. Set priorities, assign tasks, and coordinate project staff to mee...
Natural Resources Project Manager. Are you an experienced Project Manager seeking a challenging opportunity with a firm committed to our employees and providing excellence? S&ME is looking for an eager and dedicated full-time. Natural Resources Project Manager. Natural Resources Project Manager....
We're looking for a Associate Director, Regulatory Reporting Specialist to:. Prepare, analyze, and file FR Y-14 Regulatory Reports to Federal Reserve on a monthly, quarterly, and annual basis. Perform variance analysis and reconciliations between regulatory reports. Identify and raise operational ri...
EHS Compliance Specialist - ( 2400024M ). A qualified candidate will have direct relevant experience supporting or leading all aspects of EHS, including but not limited to: due diligence, auditing, and compliance assurance; EHS procedures development and training; air quality, wastewater, chemical m...
At Regions, the Business Unit Compliance Analyst is a first line of defense risk management function that ensures that business unit activities follow necessary rules and regulations and comply with legal boundaries and jurisdictions. High School Diploma or GED and nine (9) years of experience in Co...
As a Compliance Analyst, you'll play a crucial role in upholding our commitment to excellence and regulatory compliance. Support the Chief Compliance Officer and contribute to the Compliance and Ethics Program initiatives. Assist in developing the quarterly compliance report for the Board of Directo...
Compliance position that has an advanced understanding of all plan types and facilitates more complex interactions with the Plan Consultants. Ability to successfully complete and support the work outlined for the Compliance Associate roles. Reads and comprehends retirement plan provisions from plan ...
Facilitates and coordinates regulatory compliance information requests for Federal and State regulatory examinations. Works with stakeholders to implement compliance driven requirements based on licenses maintained and regulatory guidelines. Completes Annual reports including but not limited to busi...
Compliance Specialist needs 3+ years of strong experience workforce contract. Compliance Specialist requires:. Five years working experience related to Workforce contract compliance requirements, data collection, document generation. Monitor, audit and enforce Labor Compliance Program in accordance ...
You will provide site level regulatory support to the SCRI site and internal department managers in relation to the status of start-up and ongoing regulatory maintenance. You will work closely with the regulatory affairs department, site leadership and/or principle investigators to ensure compliance...
The Senior Regulatory Affairs Program Manager will play a critical role in ensuring Philips’ Ambulatory Monitoring & Diagnostics (AM&D) products are compliant by preparing comprehensive global regulatory strategies for new devices and significant post market changes. Regulatory Affairs Program Manag...