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...
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...
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...
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...
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. ...
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...
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 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 ...
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 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...
Family Health Centers of San Diego is looking for a Coding Compliance Specialist to perform audits of coding and billing, ensuring compliance with department, state, and federal rules and requirements. May spend a portion of time coding and abstracting clinic medical records, for the purpose of reim...
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...
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 ...
As a ServiceNow Engagement and Project Manager, you will play a pivotal role in overseeing a client engagement and associated ServiceNow projects. This role involved end-to-end project management, from planning and development to execution and client relationship management. Form strong relationship...
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...
Seeking 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 procedures. Co...
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...
Title: Regulatory Affairs Specialist - Hybrid. For further inquiries regarding the following opportunity, please contact our Talent Specialists:. ...
A medical device client of ours in the East Bay Area is looking to bring on a Regulatory Affairs Specialist IV position!. Years of Regulatory Affairs experience across the medical device space. International Regulatory Affairs Experience Required (Europe specifically). ...
The Regulatory Affairs Specialist will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. Senior Regulatory Affairs Specialist (Locals Only with experience composing submissions...
Director of Regulatory Affairs. You’d oversee regulatory filings, partner with external consultants, and eventually build out the regulatory function internally. Partner with external regulatory consultants and oversee the build-out of the internal regulatory function. This role will be pivotal in b...
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 team with the primary responsibility of building and maintaining Quality Systems for a next-generation sequencing clinical laboratory. Minimu...
Regulatory Affairs Manager - Permanent - Remote. Proclinical is seeking a Manager, Regulatory Affairs for a global medical device company. The Manager, Regulatory Affairs will:. Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and p...