Manager, CMC Regulatory Affairs . Reporting to an Associate Director, CMC Regulatory Affairs, the successful candidate will work independently and collaborate cross‐functionally to provide guidance to the CMC subject matter experts and manage and execute CMC regulatory submissions to facilitate the ...
Manager of Regulatory Affairs, you will be responsible for supporting MMS Dispensing products consisting of Medical Devices and Non-Medical Devices along with associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. Software experience including SaMD/SiMD experienc...
Reporting to an Associate Director, CMC Regulatory Affairs, the successful candidate will work independently and collaborate cross‐functionally to provide guidance to the CMC subject matter experts and manage and execute CMC regulatory submissions to facilitate the global development of Avidity comp...
You are a seasoned professional in the Regulatory Affairs space with specific experience with IVD and POC products. You have experience with US regulatory affairs submissions such as 510(k) and/or PMA. Have previous experience with various regulatory affairs submissions. You understand how to take t...
You are a seasoned professional in the Regulatory Affairs space with specific experience with IVD and POC products. You have experience in the past with US regulatory affairs submissions such as 510(k) and/or PMA. Have previous experience with various regulatory affairs submissions. You understand h...
Liaise with colleagues in Regulatory Affairs therapeutics teams, company local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Senior Manager, Regulatory Affairs III. Sen...
TrellisWare launched in 2000 with an innovative culture striving to push technological boundaries in the area of wireless communications.We are now a worldwide leader in highly advanced algorithms, waveforms, and communications systems that range from small form factor radio products to fully integ....
Author regulatory determinations as regulatory lead for on-market product changes, including interfacing with country market approval holders to confirm local regulatory requirements. This is a technically focused role, requiring advanced skills in analyzing information, reviewing test protocols and...
The PACE Compliance Manager ensures compliance with all federal (Centers for Medicare and Medicaid Services [CMS]), state (Department of Health Care Services [DHCS]), and other applicable regulations for the FHCSD PACE program. Family Health Centers of San Diego (FHCSD) is currently seeking a Compli...
Effectively carries out the expectations of Werfen People Managers as defined in Werfen's Role of the Manager program. Managers are responsible for managing the overall operations, business results and performance for their assigned department(s). Responsible for department functional plans, determi...
The Southern California Regional Rail Authority (SCRRA), operator of the METROLINK Commuter Rail System, is seeking a Senior Manager, Project Management who will provide leadership and oversight for day-to-day management of the Project Management functions for. ...
The Quality and Regulatory Compliance Specialist is responsible for ensuring that development processes for all in vitro diagnostic (IVD) products comply with applicable regulatory requirements and quality standards. Job Title: Regulatory & Compliance Specialist. Ensure compliance with regulator...
Director of Quality Assurance & Regulatory Affairs (QA/RA). The Director of Quality Assurance and Regulatory Affairs (QA/RA), will be a part of the executive. Minimum of 10 years of experience in quality assurance and regulatory affairs, preferably in the medical, healthcare, or Biotech sector. ...
Senior Project Manager with extensive DSA (Division of the State Architect) experience to lead ground-up construction projects in the public education sector. This role requires a leader who is not only proficient in managing complex projects but also has the ability to mentor and inspire a diverse ...
My client is seeking a GCP Compliance Manager that will provide compliance oversight. Supports the development, implementation, and maintenance of systems to advance the GCP compliance of the organization . Provides GCP strategic support to clinical study teams and establishes measures to reduc...
The Associate Director, Regulatory Affairs is responsible for establishing regulatory strategies in coordination with departmental leadership, and independently managing life cycle plans along with regulatory submissions and approvals. Associate Director – Regulatory Affairs. Establish regulatory st...
The Senior Director, Regulatory Affairs is responsible for establishing regulatory strategies in coordination with departmental leadership, and independently developing and managing life cycle plans along with regulatory submissions and approvals. Senior Director, Regulatory Affairs . Establish regu...
The Southern California Natural Resources Team is looking for a an experienced Regulatory Specialist to support permitting needs, including preparing permit applications for individual, general, and programmatic permitting efforts with the U. You will join an existing team of Natural Resources profe...
Great Ecology is looking for a natural resource-focused Regulatory & Permitting Specialist to join an interdisciplinary team of scientists and landscape architects working on restoration and natural resource management projects throughout the United States. Do you want to work on large, complex ...
Minimum of 2 years' working with clients/projects to effectively communicate Project/Program status', risk and mitigations. You can lead projects and teams and have strong communication, people and executive presence skills that help you build credibility with senior client executives. Develop reaso...
Lead business and technology outcomes for assigned program, project, or contracted service. ...
Our team members are highly knowledgeable and have diverse backgrounds in tax compliance, including tax technical compliance and reporting requirements, Pillar II compliance, process and technology enhancement, advanced calculations, and compliance and reporting for inbound and outbound businesses. ...
SummarySeeking a detail-oriented (preferably experienced) Regulatory Affairs Senior Specialist to join our regulatory dept. Work closely with hospital administration, clinical departments and external regulatory agencies to develop, implement and monitor compliance initiatives, policies, and procedu...
We are seeking a detail-oriented and highly motivated Technology Compliance Analyst to join our Information Security team. The Technology Compliance Analyst will play a critical role in ensuring our company's Technology & Security operations comply with regulatory requirements and internal policies....
As part of the Marketing Operations team, the Creative Project Manager will serve as the collaborative intermediary partner for Enterprise creative resources, namely content and design. Collaborate with project owners / marketing strategists to understand project requirements and objectives. Work cl...