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, 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 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...
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...
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...
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 Regulatory Associate will primarily focus on provider reimbursement issues, Medicare and Medicaid appeals, and audits and internal investigations, supporting the firm's robust and sophisticated regulatory and reimbursement practices. A leading national healthcare law firm is seeking a Regulatory...
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 ...
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...
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...
Family Health Centers of San Diego is looking for a Project Manager will plan, direct and coordinate activities for the delivery of the assigned project utilizing project management best practices. The Project Manager will be responsible for all aspects of the project development life cycle. The Pro...
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 ...
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...
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 Project Manager of Facilities, Design and Construction will provide a broad range of facilities construction project planning, management and analytical services to support strategic multi-disciplinary, enterprise-wide Scripps projects. Experience in the management of moderate to complex project...
The Project Manager position is ideal for someone with experience in the land development industry. The Project Manager position will grow and develop a team dedicated to land development services to execute existing work and to grow the practice. Lead project delivery in a position responsible for ...
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. Minimum of 10 years of strong Regulatory Affairs/...
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...
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 ...
Job Title: Regulatory & Compliance Specialist. 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. The specialist will ensure that all ...
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...
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. ...
Our Toxicology business unit has an opportunity for a Regulatory Affairs Specialist II which can be based in either San Diego, CA or Pomona, CA. This position will have direct responsibility for review and approval of labeling and advertising/promotional materials, approval of global product distrib...