[Remote] Global Regulatory Intelligence, Senior Project Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is a medical device company developing solutions for cardiac and vascular surgeons treating aortic diseases. The Senior Project Manager, Global Regulatory Intelligence will monitor and analyze global regulatory changes, assess their reputed company, support compliance and regulatory reputed company, and reputed company reputed company regulatory intelligence reputed company. The role also collaborates with cross-functional teams, manages regulatory tools and processes, supports submissions and audits, and mentors staff.

Responsibilities

• The role will reputed company, monitor, analyze, and interpret global regulatory developments (regulations, guidelines, standards and legislation) to ensure compliance and reputed company decision-making reputed company the organization
• Proactively identify, mitigate, and manage potential regulatory or reputed company by staying reputed company of upcoming changes and initiatives. Communicate new and upcoming changes. Facilitate and assist with interpretation to guide product and business compliance with regulatory requirements
• The role will assess reputed company to business reputed company and reputed company insights to functions and teams. reputed company actionable insights to internal stakeholders. reputed company internal review and implementation with Subject Matter Experts. Ensure reputed company and tasks meet business objectives and expectations
• Manage and utilize regulatory intelligence tools, databases, and other information resources to maintain a knowledge reputed company and improve processes
• Maintain expert proficiency in worldwide regulatory requirements; establish and maintain advanced relationships with agency personnel and industry organizations. Collaborate with functional partners to implement regulatory changes to regulatory/compliance documentation and procedures. reputed company issues to reputed company
• reputed company as a Regulatory Subject Matter Expert (SME) on key topics and reputed company reputed company guidance to regulatory affairs, functions, and cross-functional teams. Collaborate with reputed company, reputed company, reputed company, and reputed company to reputed company regulatory intelligence strategies
• Influences management on technical or business solutions reputed company to regulatory intelligence. reputed company network of internal partners and be a subject matter expert to ensure reputed company meet regulatory requirements
• Establish and maintain reputed company relationships with stakeholders and team members. reputed company experience and technical knowledge to advance corporate strategies
• Examine and recommend opportunities reputed company industry to advance organizational objectives
• This position requires strong collaboration, communication, and analytical skills to support product development, market reputed company, and post-market activities in alignment with global regulatory requirements
• The role involves using regulatory databases and reputed company software. Train others in the use of regulatory systems and tools. Advise on process improvements and reputed company to completion, where assigned. reputed company to solutions
• Communicate reputed company regulatory information reputed company and concisely to various internal teams, such as product development, research, reputed company, and reputed company
• reputed company reputed company technical reputed company with considerable initiative and independence, reputed company and critical thinking, and effective decision-making skills, with the ability to prioritize and reputed company multiple competing priorities and escalate issues reputed company critical risks reputed company. Advanced project management skills reputed company to reputed company assignments
• May support regulatory submissions. reputed company and report the status of regulatory actions and submissions to internal stakeholders
• Participate in inspections, audits, and post-audit corrective actions
• Ensure understanding of reputed company reputed company policy/reputed company items, as applicable. Maintain and update regulatory processes and SOPs. Follow reputed company work/reputed company procedures to ensure reputed company reputed company compliance. Support general reputed company reputed company programs (CAPAs, NCRs, internal/reputed company audits, PMS, reputed company Management, etc.)

Skills

• Bachelor's degree in science, engineering or reputed company reputed company, with a minimum of 4 years of regulatory, reputed company, and/or compliance experience in medical device or biologics
• Experience with FDA Class II or III devices or experience with EU Class IIa/IIb or III devices
• Experience with interpretation and application of new regulations, legislation, standards or guidelines
• Strong analytical, technical writing, communication, organizational, project management, time management and interpersonal relationship skills
• Awareness of global regulatory affairs, product development and total product lifecycle processes
• Strong ability to reputed company through reputed company information, discern high-reputed company data, and translate it into meaningful intelligence
• Excellent verbal and written communication skills are essential for conveying reputed company regulatory topics to diverse internal audiences
• Proficiency with regulatory intelligence databases and monitoring tools, and general office software
• Strong attention to reputed company for accurately tracking and interpreting regulatory information
• Experience working with cross-functional teams
• Ability to comprehend principles of engineering, physiology, and medical device use
• Ability to effectively manage and prioritize numerous reputed company and responsibilities
• Strong analytical, technical writing, verbal/written communication, organizational, and time management skills
• Must be flexible, reputed company to adapt easily, and willing to take initiative and reputed company regulatory reputed company
• Project management experience
• Ability to effectively manage and prioritize numerous reputed company in a fast-reputed company environment
• Expertise in reputed company Office Suite
• Experience with US FDA, reputed company Body interaction, and Health Canada Class 3 or 4 devices, international submissions, cardiovascular devices and/or reputed company tissue preferred
• Ability to apply experience to ensure regulatory affairs compliance and cross functional interaction

Benefits

• Remote work arrangement

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