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. ...
Senior Manager, Regulatory Affairs (Clinical). Meet has partnered with an exciting late-stage oncology biotech that is looking for a Senior Manager of Regulatory Affairs to join their team. You will support the preparation of major regulatory submissions (IND's, NDA's, BLA's). You will serve as the ...
A leading provider in the health care and digital health space is seeking a Senior Regulatory Affairs Specialist to join their regulatory team. Minimum of 5 years of experience in medical device Regulatory Affairs with a deep understanding of regulatory frameworks. As a key player in regulatory over...
Liaise with colleagues in Regulatory Affairs therapeutics teams, 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, CMC Regulatory Affairs, Biologics. ...
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).Review/approval of...
The Senior Manager in Regulatory Affairs is responsible for developing and managing regulatory strategies to ensure compliance with U. Extensive knowledge of regulatory requirements, including ICH and regional guidelines, and an understanding of current global and regional trends in regulatory affai...
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...
Reporting to the Senior Director of Regulatory Affairs, the Manager/Senior Manager, Regulatory Affairs will be responsible for strategic and administrative aspects of regulatory submissions and life cycle management, ensuring that submissions are in support of company goals, of highest quality, and ...
Job Description: Regulatory Affairs Specialist - On-site 5x a week in Alameda, CA. Provide consultation and advice to regulatory specialists regarding change control and product development. Contribute to continuous improvement initiatives within the regulatory affairs function. Experience with Japa...
Vice President or Senior Vice President, Regulatory Affairs & Quality Assurance. Lead Regulatory Affairs and Quality Assurance functions. Meet has engaged on a search for a confidential search for a VP/SVP of Regulatory and Quality with one of our biotech clients. Manage all aspects of Regulatory su...
The Executive Director/Senior Director of Regulatory Affairs will also oversee the preparation of all regulatory documents and submissions, mentor junior team members, and stay updated on changes in FDA and EU regulations. Executive Director/Senior Director of Regulatory Affairs. If you or someone y...
The Media Cloud Technical Project Manager will be responsible for overseeing the successful delivery of cloud-based media solutions, coordinating with cross-functional teams, and ensuring projects meet customer requirements and deadlines. Project Management: Lead and manage end-to-end project delive...
Structural Engineering Project Manager. We are looking for an established structural engineer ready to pursue project management and significantly contribute to growth in an already expanding firm!. Lead multiple projects that vary in size and complexity. Must possess strong project management and t...
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...
Project Manager manages the overall project direction, completion and financial outcome for assigned projects. The Project Manager is responsible for directing and mentoring on-site staff and off site activities. Oversees and assists the site safety manager;. Prepares and executes Project Execution ...
Senior Regulatory Affairs Specialist. Draft, edit, and compile technical documentation and design dossiers to support CE mark/UKCA mark regulatory filings. Prepare regulatory submissions for FDA 510(k) clearance and A2F submissions. Research regulatory requirements from FDA, CMDR, MDR, IVDR, and UK ...
Co-ordinates and prepares document packages for regulatory submissions from all areas of the organization. Keeps abreast of regulatory procedures and changes. May interact with regulatory agencies. Review reports of customer complaints and assess them for regulatory reporting. ...
Award-Winning 50-person distinguished architectural practice is actively seeking a Project Architect/Project Manager to join their growing Newport Beach studio. Join a dynamic team as a Project Architect/Project Manager, where you'll play a pivotal role in producing top-tier construction documents t...
Environmental Permitting and Compliance Specialist). Environmental Permitting and Compliance Specialist). Join Yorke Engineering, LLC, an Environmental Consulting leader in California that implements Environmental Engineering and Compliance solutions for our clients throughout California. Our missio...
Program and Regulatory Specialist. The Energy Commission seeks a Program and Regulatory Specialist to fill one position in the Special Projects Unit within the Fuels and Transportation Division. Under general direction of a Program and Project Supervisor, the Program and Regulatory Specialist will s...
Regulatory Affairs Director required by Barrington James for an initial 12-month, remote contract opportunity with the client based in South San Francisco. ...
The Regulatory Specialist is a part of Research and Development, this team is responsible for assessing ingredient safety and regulatory compliance, coordinating safety, micro, stability, compatibility and claims testing, ensuring product compliance with international cosmetic regulations, and advis...
The Technical Project Manager / Delivery Manager is expected to work with teams within the organization to identify and create a plan around budget, team structures, scope, and other items to help deliver against OKRs. Outcomes: Projects are staffed effectively and within timelines with reduced “war...
The Project Engineer will serve as the key technical resource within the Company to drive projects from conceptual design to a buildable project. The position will also be expected to travel to project sites 25-50% per month based on project needs. This role is expected to travel to project sites 25...
We are looking for an experienced Senior Project Manager to join a leading AEC organization in California! You are able to based out of one of three client office locations (Sacramento area, Los Angeles area, San Diego area). In this role, you will lead water resources projects, focusing on studies ...