Computer jobs in United States

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Refined Job Description:

• Manages and coordinates international product registration submissions, oversees internal regional regulatory activities, and ensures compliance with relevant regulations and standards.
• Leads regulatory efforts on global product registrations to meet business needs for product growth and geographical expansion.
• Engages with cross-functional teams to provide regulatory guidance, services, and capabilities supporting product launches and market expansion.
• Coordinates submissions and approvals of applications, ensuring accuracy and regional compliance.
• Plans and tracks product registration and renewal activities, managing expirations, renewals, and new applications in line with portfolio priorities.
• Manages relationships with Health Authorities to stay informed of requirements and expectations, sharing regulatory intelligence with colleagues.
• Participates in regulatory improvement projects.

• Manage international product registration submissions and oversee regional regulatory activities.
• Lead global product registration efforts to support business growth and expansion.
• Collaborate with cross-functional teams for regulatory guidance and support product launches.
• Coordinate application submissions and approvals, ensuring regional appropriateness.
• Track registration and renewal activities, managing timelines and compliance.
• Maintain relationships with Health Authorities and share regulatory intelligence.
• Participate in regulatory process improvement initiatives.

• Bachelor's degree or higher in Life Sciences, Engineering, or related fields.
• Several years of experience in Regulatory Affairs.
• Experience with Class I, II, and III medical devices.
• Deep understanding of laws, regulations, and guidelines for medical devices.
• Proven experience with international regulatory documentation and submissions, including STEDs, Design Dossiers, Technical Files, and registrations across various regions.
• Strong knowledge of EU (MDD/MDR) regulations and US regulatory submissions (IDE, 510(k), PMA).
• Familiarity with Quality Systems requirements like QSR, ISO, and GxP.
• Leadership and project management skills to handle complex projects and timelines.
• Ability to identify compliance risks and escalate appropriately.
• Stay updated with changing regulations and standards.
• Excellent computer skills, including document formatting and publishing.
• Strong problem-solving skills and adaptability to changing priorities.