The Regulatory Compliance Specialist is an integral team member working across the organization ensuring our California Provider Networks are up to date and in full compliance with state regulatory rules and regulations. In this role you will work together with claims adjusters, account managers, cl...
Job Description: Regulatory Affairs Specialist. Provide consultation and advice to regulatory specialists regarding change control and product development. Ability to interpret and apply regulatory requirements. Offer regulatory direction and interpretation on team activities. ...
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 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...
Additionally, while the position is being advertised as a Senior Regulatory Permitting Specialist, based on leveling conversations, we may determine that Regulatory Permitting Specialist is the appropriate title for you. We are seeking a seasoned project manager to join our dynamic team and help lea...
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...
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 ...
Located in the metropolitan area of Sacramento, the Adventist Health corporate headquarters have been based in Roseville, California, for more than 40 years.In 2019, we unveiled our WELL-certified campus - a rejuvenating place for associates systemwide to collaborate, innovate and connect.Whether vi...
Supports the work of the accreditation program.Assumes responsibility for processing accreditation report reviews, coordination of the site visits, and maintenance of accreditation program files.Monitors and track issues and concerns to inform accreditation program improvement initiatives and profes...
Medical manufacturer is hiring a Regulatory Affairs Specialist on a temporary basis. Previous medical device experience in a Regulatory Affairs capacity . ...
The Regulatory Compliance Specialist is responsible for ensuring compliance with all jurisdictional regulations within the designated department, mitigating potential legal and other company cost exposure. May function as a member of the bill review department leadership team, the national network t...
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. Provides regulatory guidance and defines regulatory strategy for digital products...
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. ...
Ensures staff are providing care in line with regulatory policy. Conducts ongoing regulatory unit specific tracer activity to identify opportunities for improvement and provides training. Provides ongoing education and training to staff regarding regulatory requirements. Additional Details: This pos...
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...
Immediate opening for a Quality Assurance Specialist located in Rocklin, CA (Onsite). Electronically signs as technical approver for quality on applicable documents and within the validated electronic databases. MDSAP, ISO 13485, IVDD/IVDR, and compliance to the site Quality Manual. Review and app...
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...
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...
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...
This position will be responsible for developing and executing regulatory strategies for early-phase programs and IND submissions. ...
In conjunction with Behavioral Health Director and Medical Director, establish goals for the SUD program, including program growth and planning to improve access and for SUD services to special populations in accordance with evolving patient needs; improve the quality of the MAT program. Are you a N...
Summary: Senior Food Service Manager is responsible for overseeing and training the food service operations within all Psynergy Programs residential facilities. In collaboration with the Director of Residential Services and the Board of Directors, the manager sets corporate standards for the food se...
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...
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...
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...