Provides consultation/advice to regulatory specialist for change control and product development. Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams. Handles regulatory activities involved in documentation...
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. ...
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...
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...
The Principal Regulatory Affairs Specialist will develop and implement regulatory strategies to obtain timely approvals from regulatory authorities worldwide. The Principal Regulatory Affairs Specialist will understand the regulations governing medical devices and will be responsible for assessing c...
What You Need to Know About Regulatory Affairs Specialist. Example of Regulatory Affairs Specialist Job:. Regulatory Affairs Specialist Responsibilities. What Skills Do You Need to Work as a Regulatory Affairs Specialist?. ...
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...
Medical manufacturer is hiring a Regulatory Affairs Specialist on a temporary basis. Previous medical device experience in a Regulatory Affairs capacity . ...
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. ...
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...
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/...
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...
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...
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. ...
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...
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...
This position will be reporting into the SVP of Regulatory Affairs and will be supporting Clinical Regulatory and Regulatory CMC functions. Senior Director, Regulatory Affairs (Generalist). Meet is partnering with a late stage pediatric rare disease startup looking for a high-level Regulatory Affair...
Collaborate with cross function engineering teams including software developers, system test, mechanical, electrical, technical program manager to collect each teams' hardware infrastructure requirements. Coordinate with the technical program managers, software development, operations, logistics, qu...
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...
The Enterprise Project Management Office (EPMO) Project Manager II is responsible for project management of moderate- to high-complexity enterprise-level and non-enterprise level projects and initiatives to ensure the effective development and implementation of projects involving interdepartmental a...
Likewise, sinceentering the project development business in 2010, Canadian Solar has developed, built, and connected over 9 GWp of solar power projects and over 3 GWh of battery storage projects across the world. Currently, the Company has approximately 700 MWp of solar power projects in operation, ...