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 Associate Director of Regulatory Affairs will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and De Novo submissions. Job Title: Associate Director of Regulatory Affairs. Conduct regulatory assessments for product change...
The Associate Director, Regulatory Affairs & Medical Writing will support the execution of domestic and international regulatory strategy for Codera. Support the writing strategy and execution for regulatory submissions to FDA, EMA and other regulatory authorities to support the conduct of clini...
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. Comprehensive knowledge of current US and ex-US regulations and ...
Corporate/Regulatory Associate. Our corporate/commercial health practice offers general counsel, health regulatory and governance advice to healthcare organizations, associations and professionals. We provide strategic advice and regulatory opinions on a wide variety of issues. ...
Work closely with the Director, Regulatory Ad Promo to formulate the strategic direction and develop process improvements for the Regulatory Ad/Promotion function. Independently represents Regulatory Affairs on the Medical Review Committee (MRC) and be responsible for conducting the regulatory revie...
The Associate Director, Regulatory Operations role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations. Associate Director Regulatory Operations. The individual will survey e...
Consumer Products Litigation & Regulatory Associate. The associate hired for this position will focus primarily on regulatory matters, including those involving the CPSC, FTC, and NAD. Affirmative regulatory reporting and responding to regulatory investigations. Dentons’ Consumer Products team h...
Associate Director, Regulatory Affairs. Reporting to the 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 glo...
Develop, implement, and update procedural and training manuals for the Regulatory Associates and Regulatory Department. Work closely and collaboratively with clinical project management staff to plan and delegate collaborative tasks for study coordinators and regulatory associates to ensure completi...
The Associate Director of Regulatory Affairs will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and De Novo submissions. Job Title: Associate Director of Regulatory Affairs. Conduct regulatory assessments for product change...
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 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...
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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 . The position i...
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 ...
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...
The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. Regulatory Affairs Specialist I. Drafts, edits and compiles technical documentation ...
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...
The Director, Regulatory Affairs will support the development and execution of domestic and international regulatory strategy for Codera. The Director, Regulatory Affairs is responsible for ensuring documentation is clear and accurate, complies with regulatory requirements, conforms to company quali...
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...
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. Support preparation of internal qual...
We are in search of an accomplished and dynamic Senior Director of Regulatory Affairs to join our team. Reporting directly to the Chief Medical Officer, the Senior Director will provide strategic leadership, ensuring compliance with global regulatory standards while supporting organizational objecti...
We have an exciting opportunity for an Electromagnetic Aircraft Launch System (EMALS) and Advanced Arresting Gear (AAG) Production Project Manager to join our team located in Rancho Bernardo, CA. The Production Project Manager plays a critical role in meeting financial business objectives and delive...
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...