A company is looking for a Regulatory Affairs Specialist to support US and OUS regulatory activities for Class II and III products.
Key Responsibilities : Participate in product development teams to provide regulatory supportCompile technical documentation for global regulatory submissions and registrationsReview QMS and product changes for compliance with regulatory requirementsRequired Qualifications : Bachelor's Degree in STEM, Medicine, or Life Science1-2 years of experience in medical device product development or related fieldsFamiliarity with medical device regulations in the US and / or EUKnowledge of relevant standards and guidance documents (e.
g., 21 CFR 820, MDR)Experience in regulatory affairs, clinical affairs, Quality, or Engineering is required
Regulatory Affairs Specialist
A company is looking for a Regulatory Affairs Specialist I to manage regulatory documentation and submissions. ...
Regulatory Affairs Specialist Project Lead
Monitor emerging regulatory policy issues, including issues arising from North American regulatory authorities, legislatures, within the pharmaceutical industry or elsewhere, and identify those issues likely to impact R&D pipeline, regulatory strategy or product portfolio. Minimum 3 years in Regulat...
CFO Compliance Specialist - Security Clearance Required
Currently, ManTech is seeking a motivated, career and customer-oriented CFO Compliance Specialist to join our team at Bolling AFB, Washington, D. Mid Special Programs CFO Act Compliance Specialist. The applicant will be required to answer certain questions for export control purposes, and that infor...
Johns Hopkins Bloomberg School of Public Health Senior Program Manager
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Global Regulatory Affairs Director (Vaccines)
This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data. Accountable to the asset GRL ...
Director, Regulatory Affairs
The Director, Regulatory Affairs develops and implements regulatory compliance and strategies that enable MaxCyte to meet business needs as well as safety, quality, and regulatory requirements. The Director, Regulatory Affairs will head the Regulatory function at MaxCyte. Utilizes knowledge of regul...
Data Compliance and Monitoring Specialist
Data Compliance and Monitoring Specialist. Data Compliance and Monitoring Specialist. The incumbent is responsible for monitoring and reviewing financial transactions/data on an enterprise-wide basis to prevent and detect errors and fraud and to ensure compliance with laws, regulations, policies, an...
Revenue Operations Program Manager
A company is looking for a Revenue Operations Program Manager to support the operations of the Revenue organization. ...
Compliance Analyst
This position will support the Foundation’s conservation award-making activities by focusing on the areas of compliance and risk analysis relating to the Foundation and its subrecipients and for programmatically funded contractors. Review and approve applicant budgets to ensure compliance with...
AV - Technical Program Manager
We are looking for a Technical Program Manager to know, understand, build, and deliver a full range of Network and Audio-Visual (AV) products including conference rooms, presentation rooms, training rooms, wireless deployments, mobile builds, IDF expansions, and Managed Network Environments. The Tec...