Palo Alto, CA seeks Regulatory Affairs Specialist: Examine, evaluate & investigate eligibility for or conformity with laws & regulations & perform other compliance & enforcement inspection & analysis activities. ...
JCW is working on an exciting search for Regulatory Affairs Specialist III for global Biotech who is expanding their growing team. In this role you will play a key role in planning, managing, and tracking of regulatory submissions and documentation for the production of biological medicines. Account...
We are hiring a Senior Regulatory Affairs Specialist for our Diagnostics Regulatory Affairs team who will be responsible for new product development, on-market, and international regulatory activities associated with US FDA, EU Notified Body, and other international regulatory agencies. Autonomously...
Kelly® Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a 1-year contract opportunity with a leading molecular diagnostics company based in Sunnyvale, CA. Regulatory Affairs Senior Specialist, Global Market Protection. The Regulatory Affairs Senior Specialist is responsible f...
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. ...
Assist in the preparation of regulatory submissions in support of IVDR implementation of Toxicology and Therapeutic Drug Monitoring Assays. Organize and assist in the review of materials for inclusion in regulatory submissions both in the EU and worldwide. Support the preparation of dossiers and sub...
The Staff/Principal Regulatory Affairs Specialist will function as a subject matter expert and will be part of a high-performing RA team and responsible for contributing to the development of regulatory strategies, preparing U. Represent regulatory in clinical program teams and communicate regulator...
Regulatory Affairs Specialist will be responsible for assisting and supporting core regulatory affairs activities for the business, in addition to supporting advertising, promotional and standards review. Provide expert regulatory advice during the product design and development phases, ensuring reg...
We are looking for a detail-oriented clinical professional to join our growing Regulatory team as a Clinical Regulatory Coordinator (CRC) or Clinical Regulatory Specialist (CRS). Clinical Regulatory Coordinator/ Specialist. Work closely with Clinical Operations and Regulatory Affairs to ensure compl...
In collaboration with the Director of Accreditation, The Accreditation and Regulatory Compliance Specialist manages all aspects of accreditation, regulatory and hospital licensure compliance across the healthcare enterprise. Identifies opportunities for improvements based on evidence based practices...
In collaboration with the Director of Accreditation, The Accreditation and Regulatory Compliance Specialist manages all aspects of accreditation, regulatory and hospital licensure compliance across the healthcare enterprise. Identifies opportunities for improvements based on evidence based practices...
Regulatory Affairs Specialist will be working to build best in class products. The ideal candidate will have experience building a regulatory strategy and supporting documents from scratch, including developing, leading, and driving proactive execution of a global regulatory strategy. Acts as a regu...
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...
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 Labeling Specialist on a temporary basis. ...
Regulatory Affairs Specialist will be responsible for assisting and supporting core regulatory affairs activities for the business, in addition to supporting advertising, promotional and standards review. Provide expert regulatory advice during the product design and development phases, ensuring reg...
Medical manufacturer is hiring a Regulatory Affairs Specialist on a temporary basis. Previous medical device experience in a Regulatory Affairs capacity . ...
Collaborate with cross-functional teams to drive regulatory project management activities. Manage timely completion of new product registrations and maintain global regulatory approvals to market software devices. Collaborate with external partners including regulatory agencies, authorized represent...
Kelly® Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a 1-year contract opportunity with a leading molecular diagnostics company at their headquarters in Sunnyvale, CA. Regulatory Affairs Senior Specialist, Global Market Protection. The Regulatory Affairs Senior Specia...
With 5-8 years of experience, you possess deep professional know-how and experience in regulatory affairs. Candidates have a mastery of regulatory guidance documents and requirements for FDA 510(k) submissions, Health license applications, and EU MDR technical files. Candidate expertise includes det...
Kelly® Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a 1-year contract opportunity with a leading molecular diagnostics company at their headquarters in Sunnyvale, CA. Regulatory Affairs Senior Specialist, Global Market Protection. The Regulatory Affairs Senior Special...
Responsibilities also include keeping senior management informed of regulatory status of products and significant regulatory issues as well as maintain proficiency in global regulatory requirements. Principal Regulatory Affairs Specialist. Proven expertise in all aspects of Regulatory Affairs; Strat...
Kelly® Science & Clinical is currently recruiting for a Senior Regulatory Specialist for a contract opportunity with a leading molecular diagnostics company at their Sunnyvale, CA location. Senior Regulatory Affairs Associate, New Product Development. This position is a 6-month contract with the...
Assist in the preparation of regulatory submissions in support of IVDR implementation of Toxicology and Therapeutic Drug Monitoring Assays. Tasks include:o Organize and assist in the review of materials for inclusion in regulatory submissions both in the EU and worldwide. Support the preparation of ...
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...