Senior Regulatory Affairs Specialist. Master’s Degree in Regulatory Affairs preferred and may be used in lieu of direct regulatory experience. Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes. Understand, investigate and evaluate regulatory ...
The Principal Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements. The Principal Regulatory Affairs Specialist is an individual contributor that works closel...
The Principal Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements. The Principal Regulatory Affairs Specialist is an individual contributor that works closel...
As the Senior Global Regulatory Affairs Specialist, you will be responsible for regulatory activities related to the development and implementation of global regulatory strategies to support the submission, filing, and registration of multiple indications (clinical applications or “apps”) in general...
Principal Regulatory Affairs Specialist. A leading medical device and diagnostics company is seeking a Principal Regulatory Affairs Specialist to support their growing product portfolio. Developing strategies for regulatory approval on a global scale for new and modified products. Prepare regulatory...
The Senior Regulatory Affairs Specialist overseeing advertising and promotional Regulatory responsibilities, works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. The Senior Regulatory Affairs Specialist c...
As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment. Principal Regulatory Affairs Specialist. This position performs specialized level work assignm...
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 ...
This **Regulatory Affairs Specialist** **II** will work out of our Pleasanton, CA location in our Heart Failure Division. As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwid...
As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment. Principal Regulatory Affairs Specialist. This position performs specialized level work assignm...
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...
Principal Regulatory Affairs Specialist. 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. 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...
Provide regulatory support for clinical and post-market activities including adverse event reporting, labeling updates, and regulatory inquiries. Minimum of years regulatory affairs experience required with Bachelor's degree. Minimum of years regulatory affairs experience with Advanced degree. Work ...
The specialist works across the organization in participating in design control activities, US and Canada regulatory assessment and submissions, and liaises with global regulatory counterparts on a wide range of products. Provide regulatory input and oversight to product development and manufacturin...
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...
Senior Staff Regulatory Affairs Specialist. Senior Staff Regulatory Affairs Specialist. Open Field Visualization premarket regulatory team, specifically supporting business development activities, actively participating in the integration of Regulatory roles and responsibilities for newly acquired t...
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...
Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products. Serve as the principal regulatory affairs liaison to FDA and other health authorities for assigned Investigational New Drug (IND) and New Drug Applicatio...
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...
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...
As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Prepares robust ...
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...
Senior Regulatory Affairs Specialist (Multiple Positions), Becton Dickinson and Company, Milpitas, CA. Apply deep understanding of global regulatory landscape to analyze and compile country-specific regulatory requirements. Device/diagnostic, biologic, or pharmaceutical industry in Regulatory Affair...
Represents RA in new product development team(s) by providing regulatory guidance, such as anticipating regulatory obstacles and emerging issues, and identifying solutions, through the product development cycle and coordinating cross functional team inputs. Responsible for assessing and documenting ...