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 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...
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 ...
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...
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...
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...
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...
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...
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...
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...
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 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...
Assist Regulatory Management with product deviation reporting to the FDA. Advanced understanding of Good Manufacturing Practices (GMPs), FDA & EU Regulatory requirements. ...
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 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...
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...
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...
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...
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...
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...
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...
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Regulatory Affairs Specialist II:. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. ...
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...