A company is looking for a Principal Regulatory Affairs Specialist for Digital Health Apps.Key Responsibilities : Develop and implement medical device regulatory strategies for global approvalsPrepare and submit regulatory submissions for Class IIa Digital Health apps and other productsInteract with regulatory agencies, create technical documentation, and support product development teamsRequired Qualifications : Bachelor's degree with 7 years or advanced degree with 5 years of regulatory experience in medical device, biotech, or pharmaceutical industriesExperience with SaMD and Digital Health apps, ISO standards, and medical device software regulationsKnowledge of US, EU, and international medical device regulationsRegulatory Affairs Certification (RAC) or Master's degree is a plusBackground in diabetics is desirable
Principal Regulatory Affairs Specialist
A company is looking for a Principal Regulatory Affairs Specialist for Digital Health Apps. ...
Senior Regulatory Affairs Specialist
A company is looking for a Senior Regulatory Affairs Specialist, Medical Devices. ...
Regulatory Affairs Specialist
A company is looking for a Regulatory Affairs Specialist. ...
Research Regulatory Specialist Sr (100% remote)
Coordinate the day-to-day administrative activities of the clinical research trials program, including mentoring Research Regulatory Specialists with a focus on study activation. Lead a team of Research Regulatory Specialists and/pr Coordinators. Prepare and/or provide guidance to Regulatory Special...
Compliance Specialist
Credit Union Compliance Expert (CUCE), Bank Secrecy Act Compliance Specialist (BSACS) or Certified Regulatory Vendor Program Manager (CRVPM). Maintains and enhances an effective compliance management program that provide a framework to manage compliance related risks, identifies relevant risks and o...
Affordable Housing Compliance and Training Specialist
Affordable Housing Compliance and Training Specialist to assist with the Project Based Section 8 and Low-Income Housing Tax Credit Regulations. The Affordable Housing Compliance and Training Specialist takes the lead r. ...
Data Warehouse Analyst
Key Responsibilities:Plan, design, develop, and maintain data models and integration pipelines in SnowflakePerform ELT/ETL development and ensure data quality through thorough testingProvide production support and create documentation for database objects and development activitiesRequired Qualifica...
Regulatory Affairs Associate
As a Regulatory Submissions Coordinator, you will be responsible for coordinating and preparing document packages for regulatory submissions across all organizational areas. Job Title: Regulatory Submissions Coordinator. Staying updated on regulatory procedures and changes will be crucial to your su...
Compliance and Audit Analyst
Develop and manage information security initiatives for multiple IT functional area across the enterprise related to risk management, mitigation and response, compliance, control assurance, and user awareness. ...
Financial Data Analyst
Proven experience as a Business Analyst, Data Analyst, or similar role with a focus on data analysis and reporting. Softworld, a Kelly Services company, is looking for an experienced Financial Data Analyst with a strong proficiency in Excel, and ideally experience using Power BI. Business Analyst / ...