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.
...input that helps train and evaluate next-generation AI systems. No prior AI experience is required, your C#/.NET and database expertise is the focus. Key Responsibilities Design, develop, and maintain reliable backend services and APIs using C# and .NET frameworks...
...A prominent consulting firm is seeking a Court Reporter for engagement at the VA Health Care Center in Harlingen, Texas. The role involves... ...offers a comprehensive benefits package and the opportunity to support federal clients in healthcare settings.#J-18808-Ljbffr...
...Job Description: Backend C#/.NET Developer Backend C#/.NET Developer Job Type: Contract Location: Remote Job... ...and perform through high-quality, real-world input. No prior experience in AI is required - your domain knowledge is what matters....
...On Call - Parking Enforcement Officer Pay Rate: $20.00 per hour Job Type: Full-Time Location: Pacifica, California Shift: On-Call, Monday to Friday 10am to 6:30pm Applications will be accepted until job is closed. What We're Looking For: Direct...
...Plan, lead and motivate residents to participate in daily planned activities. Maintain accurate records of resident interaction and... ...participation. Establish one-on-one relationships with residents. Assist the director in planning, coordinating, and implementing...