Oversees all aspects of planning, design, and execution of multiple, small routine projects or a moderately complex project. Assists in developing timelines and ensures adherence to deadlines. Manages financial aspects of projects and other administrative duties. Handles external correspondence and drafts reports and other communications. Essential Functions This is a pro

. Work Schedule and Additional Information Full time employment Work hours are 9 00 AM to 5 00 PM, Monday Friday, with 30 minute lunch. Work hours may vary based on operational needs. Telework You may have the opportunity to telework, part time after the successful completion of the required probationary period. In order to telework, you must have a securely configured hi

. Work Schedule and Additional Information Full time employment Work hours are 9 00 AM to 5 00 PM, Monday Friday, with 30 minute lunch. Work hours may vary based on operational needs. Telework You may have the opportunity to telework, part time after the successful completion of the required probationary period. In order to telework, you must have a securely configured hi

. Work Schedule and Additional Information Full time employment Work hours are 8 00 AM to 4 00 PM, Monday Friday, with 30 minute lunch. Work hours may be negotiable based on operational needs. Telework You may have the opportunity to telework, part time after the successful completion of the required probationary period. In order to telework, you must have a securely confi

. Work Schedule and Additional Information Full time employment Work hours are 8 00 AM to 4 00 PM, Monday Friday, with 30 minute lunch. Work hours may be negotiable based on operational needs. Telework You may have the opportunity to telework, part time after the successful completion of the required probationary period. In order to telework, you must have a securely confi

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

. Work Schedule and Additional Information Full time employment Work hours are 9 00 AM to 5 00 PM, Monday Friday, with a 30 minute lunch. Work hours may vary based on operational needs. Telework You may have the opportunity to telework, part time after the successful completion of the required probationary period. In order to telework, you must have a securely configured

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

The Lead Regulatory Affairs Specialist leads the preparation of document packages for regulatory submissions for new and sustaining enhanced technologies, software enabling and robotics systems within the Surgical Intelligence (SI) portfolio, to ensure compliance with local and regional registration requirements. The Lead Specialist will be responsible for coordinating pr

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 Center for Public Health Law Research (CPHLR or Center) housed at Temple University's Beasley School of Law supports the widespread adoption of scientific tools and methods for mapping and evaluating the impact of law on health. The CPHLR team works by developing and teaching legal epidemiology methods; by researching laws and policies that influence health to support

We are recruiting for experienced Regulatory Affairs Professionals on various levels. In this role, you will focus on clinical trial submissions. We are looking for someone who is experienced in CTA, EU CTR knowledge and experience would be a strong plus. The role can be based in our office in Madrid or remote. Key Deliverables in the role Manage the local submissions (as

Regulatory Affairs Consultant must have an understanding of the organization's consulting models and methodologies, as well as good knowledge of what services PC provides. The Consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. This key role in the organization ensures the timely performance of wo

1. Should have experience in eCTD, NeeS and paper formats. 2. Working experience in all major emerging countries (EU, GCC, US, ASEAN etc.) 3. Compilation, publishing, and technical quality control of Regulatory submissions including technical troubleshooting to ensure issues with submissions are resolved and deadlines met. 4.Should have experience in handling submission g