Supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's de ...gree. Typically reports to a supervisor or manager. Occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. Typically requires 2 -4 years of related experience.More Show Less
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Ready to Develop the future of water. . Regulatory Affairs Specialist II. Grade 12. $88,352 - $141,364. . . Open: December 8, 2025. Close: December 22, 2025. . One position available. filled based on the candidate’s qualifications. Starting salary will be between minimum and midpoint in the range. . ABOUT US. Are you passionate about making a difference and being a trusted steward of our most precious resource. UOSA is seeking a highly motivated ...
Position Summary. The Regulatory Affairs Specialist II supports the company’s regulatory initiatives to meet strategic short- and long-term objectives. This includes assisting with the preparation and submission of regulatory documents, maintaining compliance with applicable regulations, and supporting cross-functional teams during product development and post-market activities. The Specialist works closely with the Principal Regulatory Affairs S...
Responsibilities. Prioritize and monitor cases throughout the day, provide status updates as necessary. Support the IVDR labeling conversion and revisions of technical files for appropriate products that are due to convert to the new IVD Regulation. Work cross-functionally in weekly meetings to ensure labeling conversion follows the plan. Monitor monthly manufacturing schedule, track change requests and monitor manufacturing timelines. Update lab...
Job Description. This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analysi...
Job Description. This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analysi...
Responsibilities. This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analys...
Responsibilities. This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analys...
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Working at Abbott. At Abbott, you can do work that matters, grow, and learn, care for yourself and f...
About CooperSurgical. JOB DESCRIPTION. CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thin...
Responsibilities. As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory approval, ensuring products and procedures comply with regulatory agency specifications. This new team member will support necessary regulatory activities required for clinical trial operations and product market entry. Prepares robust regulatory applicat...
Job Description. This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of procedures and systems designed to ensure that the product development process addresses all regulatory requirements as well as the objectives of the business. Requires data analysi...
