• Assesses links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy
• Remediation of regulatory documentation in accordance with relevant regulatory requirements for US 510(k)
• Remediation of EU MDR Technical Documentation File in accordance with relevant regulatory requirements for Class IIa medical device
• Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies
• Provides guidance to integrate regulatory considerations into global product entry and exit strategy
• Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles
• Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations
• Negotiates with regulatory authorities on complex issues throughout the product lifecycle
• Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution
• Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures
• Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
• Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions
• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions
• Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans
• Provides regulatory guidance on strategy for proposed product claims/labeling
• Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims
• Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees
...of Responsibility: Participate in the Tax Review component of the AdventHealth (AH)... ...Compensation Review Committee (PCRC) review; Prepare the agenda and data packets for all PCRC... ...to monitor compliance with the federal income tax limitations with respect to private...
...Medical Products (ISO, IPEC). Must possess knowledge and familiarity with computers and various software such as MS Word, MS Excel, MS Access and MS Project. Ability to add, subtract, multiply and divide in all units of measure using whole numbers, common fractions and...
...The Body Shop Manager will lead and direct the daily operations of the Exeter, NH and Bow, NH auto-body repair departments, focusing on profitability, employee retention, and overall customer satisfaction. This position will report directly to the Vice President of Service...
Project Assistance & Process Follow-up- Assist the project manager in formulating warehousing automation project plans, track task milestones, record progress, and compile weekly/monthly reports.- Participate in the implementation of warehousing automation projects, including...
...innovative digital solutions that solve real-world problems. We believe great user experiences are at the core of successful products. We are looking for a passionate and creative UI/UX Designer (Entry Level / Fresher) who is eager to learn, grow, and contribute to...