The Associate Director / Director of Regulatory Affairs will help develop regulatory strategy and be an active partner in drug development project planning and execution. ASSOCIATE DIRECTOR / DIRECTOR OF REGULATORY AFFAIRS -. Effectively coordinate with Regulatory Operations to ensure on-time prepar...
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...
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. ...
We’re currently seeking a Regulatory Affairs Director for a small, yet exciting CRO focused on IVD clinical studies. Oversee regulatory submissions, managing relationships with regulatory agencies, and guiding clients through the regulatory landscape. Lead the regulatory strategy and operations for ...
Splunk is looking for a motivated Senior Analyst who is passionate about delivering technology assurance, advisory, compliance and risk management services to the company. You will ensure proper identification and mitigation of risks / processes / internal control gaps that have potential operationa...
The manager will handle regulatory activities including drafting and reviewing sPMA’s, pre-submissions, and other filings. Prepare, collect, or coordinate information and prepare regulatory documentation for submission to regulatory agencies or commercial partners. Provide regulatory support to exis...
The Manager, Regulatory Affairs, is responsible for leading Carlsmed’s regulatory submissions and successfully interacting with regulatory agencies. Lead the Regulatory Affairs function, including creation and/or oversight of US and International regulatory submissions. Represent Regulatory Af...
As a member of PointClickCare’s Legal and Compliance team, In the role of Compliance Analyst, you will be instrumental in driving key initiatives and projects that have a substantial impact on PointClickCare, its customers, and other stakeholders. Assist in the development of, and ongoing updates to...
We're currently seeking a Regulatory Affairs Director for a small, yet exciting CRO focused on IVD clinical studies. Oversee regulatory submissions, managing relationships with regulatory agencies, and guiding clients through the regulatory landscape. Lead the regulatory strategy and operations for ...
Strong data analysis skills with the ability to quickly identify trends and root causes and transition analysis into actionable projects. Manage initiatives throughout the project lifecycle, from inception to completion. ...
With limited direction, this position is responsible for performing contract and/or procurement analysis to ensure compliance to regulations, contractual requirements and Company policy. Maintains awareness of regulatory changes to ensure compliance with appropriate statutes, regulations and Company...
The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Position: Sr Regulatory Affairs SpecialistLocation: Sunnyvale, CaliforniaPosition...
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...
Utilize project management best practices to develop comprehensive project plans, establish timelines, allocate resources, and track progress towards cost-saving targets. Lead Value Analysis/Value Engineering (VAVE) projects aimed at identifying cost-saving opportunities across product lines while m...
Applies basic knowledge of compliance, business, analytical, and communication skills to support compliance programs and processes that promote compliant and ethical behavior, meet regulatory obligations, and prevent, detect, and mitigate compliance risks. This position will focus on compliance with...
The Senior Compliance Analyst has advanced knowledge of the job area and technical systems and practices, and advanced technical skills and reporting abilities. Maintains the compliance FWA audit program, including schedules, standards, processes, reports and tools in close collaboration with Compli...
You'll be a member of the Content and Policy Analyst that define content standards and outline policy and inclusion criteria for our FCC and Trade Compliance business. You will support the management of our World Compliance data, specifically the maintenance and dissemination of our researcher-facin...
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 ...
Maintain quality system records in compliance with regulatory requirements utilizing current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP). Work with MSAT, Compliance and Quality Assurance to resolve quality issues. Manage, lead, and implement operational excellence eff...
Experience in managing projects related to database migration and application modernization. ...
Work closely with the project evaluator in the maintenance of quarterly data collection processes for annual reports. Supervisory and managerial responsibilities include all clinically based staff, including the social worker, community health worker, and advanced practice nurses. ...
Continually reviews status of the project(s) and budgets to ensure project(s) are completed on time and within budget. Develops mechanisms for monitoring project progress and for intervention and problem solving with project management, line management, and the customer. Assist with development of p...
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps...
Senior Regulatory Affairs Specialist. Experience: 5-8 years of experience in medical devices; 5+ years of experience in regulatory affairs; US 510(k) submission experience required. Regulatory Affairs Certificate (RAC) desired. The position will work closely with cross-functional teams and provide e...