Job-ID29247439Reference25-02134 Responsibilities: Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions. Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions. Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products. Evaluate the risk of proposed regulatory strategies; may offer solutions. Reviews proposed labeling for compliance with applicable US and international regulations. Writes/manages the development of package inserts. Reviews and evaluates promotion and advertising material for compliance with applicable regulations. Reviews proposed product changes for impact on regulatory status of the product. Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electronic submissions. Leader in the development of dossiers for registration of products in countries outside the US; including authoring and/or publishing electronic submissions. Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products. Expected Areas of Competence. Demonstrated strong writing and communication skills. Strong attention to detail, ability to multi-task. Knowledge of overall business environment, the orthopedic industry, and the marketplace. Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs, and combination products. Ability to function well as a member of the team and build relationships between RA and other areas of the organization. Able to identify risk in Regulatory strategies. Knowledge of FDA regulations (including labeling regulations) and regulations outside the US preferred. Basic computer skills, including Microsoft Office Suite. Requirements: US bachelor's degree in life sciences, technical (engineering) or related field (or non-US equivalent). A minimum of 3 years' experience in Regulatory Affairs Advanced experience in the areas that may include preparation of dossiers for product registrations outside the US; preparation of submissions to the FDA strongly preferred. Regulatory Affairs Certification (US or EU) preferred. A combination of education and experience may be considered.
...Whitson Plumbing and Electric , a subsidiary of Clear Cloud Solutions Inc, is a fast-growing Plumbing, Electric, Construction, and Security Systems Integration company headquartered in Southern California. We specialize in the commercial, industrial, and government...
DYAD Elective Music Consultant AALJob DetailsJob ID: 5668428Application Deadline: Posted until filledPosted: Apr 24, 2026 5:00 AM (UTC)Starting Date: To Be DeterminedJob DescriptionThird Future Schools is a highachieving and growing network of charter schools...
...Participate in collaborative, cross-discipline integrated product teams, employ agile software development techniques and resources to develop, test, and integrate complex software and systems solutions for aerospace and defense applications \n Responsible for some or...
...complexity as they meet today's needs and transition to more sustainable solutions. Position Summary Responsible for executing helper duties to assist assigned crew. Primary Responsibilities Must have knowledge of applicable safety rules; use basic tools and...
...Registered Nurse (RN) Inpatient Rehab Winston-Salem, NC, United States Where You Will Work: Our Inpatient Rehabilitation Unit operates as an accredited rehabilitation facility; provides specialized, evidence-based care for patients recovering from complex...