CMC Regulatory Affairs Specialist performs regulatory assessment of changes, interpreting the current, approved and planned clinical regulatory landscape by contributing to the regulatory submission f...
read moreRegulatory Affairs Project management experience. Integration liaison role between Global/Regional/Local RA and cross-functional team members to streamline, manage and track all integration projects a...
read moreImplement regulatory strategies for launching new products and maintaining existing products. Review and approve product labeling and promotional materials to ensure regulatory compliance. Create regu...
read moreProvide regulatory support for new product registrations, Certificates of Free Sale, labeling compliance, SDS authoring, PIF preparation per various international specific country registration require...
read moreCoordinates the collection of documents, records, reports, and data from the Development, Clinical Affairs, Quality, and Operations Departments for inclusion in regulatory documents. Responsible for t...
read moreProvides administrative support for regulatory affairs manager. Minimum 1-3 years' experience in Regulatory Affairs in the medical device industry. Conducts regulatory assessments and determines need ...
read moreParticipates in the preparation, planning, coordination and oversight of planned and unplanned regulatory survey and reporting by The Joint Commission, New York State Department of Health, CMS and oth...
read moreExperience working on regulatory or governmental matters, directly or in a support role, with state energy regulators or legislators; a diversity of operational or staff position experience working fo...
read moreThe PV Analytics and Reporting Specialist, PV Analytics Center of Excellence contributes to the ongoing development, implementation, and successful execution of the scientific, operational, and regula...
read moreThe Regulatory Affairs Specialist coordinates, facilitates, and reports on post-market regulatory programs. Implements regulatory activities such as obtaining global regulatory clearances and/or appro...
read moreThe Regulatory Affairs Specialist will review and approve Dietary Supplement/Food labels for technical accuracy and compliance to all mandated regulatory requirements, provide information to rectify l...
read moreCertification is a plus (such as RAC from the Regulatory Affairs Professionals Society. Compile, prepare, and review regulatory submission to US and EU. Monitor applications under regulatory review an...
read moreThis position is responsible for the preparation of regulatory submissions required to market medical devices in both the and Europe, support of international product registrations and related regulat...
read moreEligibilities & qualifications.
Working knowledge of relevant federal and state regulatory programs (e.
The Specialist Regulatory Affairs is responsible for ensuring that the assigned Brand products meet and follow all regulatory requirements necessary to conduct business globally. Head Quarters Regulat...
read moreRegulatory Affairs Specialist Project Lead I (Scientific). This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be res...
read morePrepare new/revised label packaging for regulatory submissions to the USDA and maintain regulatory documents to ensure site compliance. Support regulatory filing submissions with the USDA for both dom...
read moreRegulatory Affairs Documentation Specialist. A Regulatory Affairs Documentation Specialist utilizes strong written communication skills to enhance the level of documentation maintained within the Depa...
read moreRegulatory expert support IVDR teams, implements regulatory strategies for IVDR activities; provides regulatory leadership; collaborates with the regulatory staff from other business units, companies,...
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