Job Description: Regulatory Affairs Specialist. Provide consultation and advice to regulatory specialists regarding change control and product development. Contribute to continuous improvement initiatives within the regulatory affairs function. Ability to interpret and apply regulatory requirements....
We are currently seeking a Senior Regulatory Affairs Specialist to drive regulatory strategies and submissions for medical devices. Senior Regulatory Affairs Specialist. Hands-on experience with major regulatory submissions and managing interactions with regulatory agencies. Develop and implement gl...
In this role, you will Perform regulatory assessments for product changes including regulatory reportability decisions Work with cross functional team and international regulatory colleagues to develop and implement global regulatory strategy to support business global expansions Support regulatory ...
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...
From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including p...
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Regulatory Affairs Specialist II:. Works in close collaboration with internal customers and supports multiple projects to align on regulatory strategy to achieve business objectives. ...
Medical manufacturer is hiring a Regulatory Affairs Specialist on a temporary basis. Previous medical device experience in a Regulatory Affairs capacity . ...
This position will be responsible for developing and executing regulatory strategies for early-phase programs and IND submissions. ...
Director/Senior Director of Regulatory. An Oncology based biotech client of ours is looking to fill their Director/Senior Director role based out of their facility in the San Francisco Bay Area. The Director/Senior Director will be responsible for…. The Director/Senior Director should have the follo...
They are looking to bring on a Senior Director, Regulatory Affairs to the team. Provide strategic and operational leadership in regulatory affairs, including regulatory strategies, clinical study requirements, and marketing approvals in various regions. Utilize deep knowledge of regulatory requireme...
The Labor Compliance Analyst monitors, audits and enforces the LACCD Labor Compliance Program in accordance with the LACCD and DIR accepted practices. Additionally, the analyst performs LCP field interviews and coordinates with contractors/subcontractors on all projects to ensure compliance with Cal...
A degree in a life science, chemistry, or chemical engineering or closely related discipline with a graduate degree preferred and at least 10 years of experience in pharmaceutical regulatory affairs, that includes, but cannot be limited to, CMC regulatory affairs. Associate) Director, Regulatory Aff...
Regulatory Affairs Manager - Permanent - San Francisco Bay Area. 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 int...
My client is seeking a Director, Regulatory Affairs to join their Regulatory team. At least 8-10+ years of Regulatory Affairs experience. Be able to prepare nd lead successful regulatory meetings and major health authority interactions. Extensive global regulatory submission experience (IND/CTA/BLA/...
Director/Senior Director, Regulatory Affairs. They are looking for a Director or Senior Director of Clinical Regulatory Affairs to join their team. Develop and execute Clinical Regulatory Affairs strategies to support clinical development objectives. Minimum 7 years specifically in clinical regulato...
Director, CMC Regulatory Affairs. Serve as the PDM regulatory representative on project teams, provide CMC regulatory support for the clinical development of the investigational product(s), and ensure applicable regulatory requirements are appropriately met. The position is responsible for providing...
We are supporting a small growing biotech in the Bay Area looking for a Senior Regulatory Affairs Associate!. Atleast 2 years experience in a regulatory setting at a biotech company. Strong foundation in biological or physical sciences, with the ability to apply scientific knowledge to regulatory ma...
The Senior Labor Compliance Specialist will provide overall compliance support to projects requiring prevailing wage and other specific labor requirements. Certified Labor Compliance Specialist (CLCS) or similar certification is a plus. Be responsible for labor compliance company-wide. Perform perio...
Compliance & Ethics Specialist. Perform field and desk monitoring to ensure compliance with to relevant laws and regulations. Track, analyze, and report on compliance monitoring progress, identifying trends and potential risks. Provide compliance guidance and support for various initiatives and proj...
The Documentation Specialist will support all aspects of quality and regulatory documentation, quality system implementation, document management, and change control to ensure that the documentation system, procedures, and records meet quality standards and regulatory requirements. The Quality Regul...
Our client has a unique opportunity for a highly skilled Principal Regulatory Specialist to join a growing team working on novel technology in the Neurological/Spine space. Lead regulatory strategy and submissions for Class 2 & 3 products, including PMA and 510(k) applications. Develop and execute r...
We are seeking a Principal Regulatory Affairs Specialist to support regulatory strategies and submissions for Class III medical devices. Lead regulatory submissions for Class III devices and maintain regulatory communications. This role will involve collaborating with cross-functional teams, contrib...
CRM Implementation Program Manager - Large Scale Enterprise CRM Implementation Hybrid remote / Sacramento or SF Bay Area - there will be some travel between San Francisco and Sacramento and is a Hybrid role with Remote work. Manages all aspects of CRM implementation program delivery including resour...
The Program Manager will report to the Director of Operations and manage all programmatic operations and activities. The Program Manager will advance HAMO’s mission by providing excellent customer service to our community partners, including administering diaper delivery logistics, streamlining syst...
Assist project team in planning and design of Solar PV and BESS projects. Manage existing projects and assist in estimating new projects as appropriate. Lead weekly project management meetings to effectively communicate project progress and expectations to all stakeholders. Supervise construction pr...