[Remote] Senior Manager, Combination Product Development

Note: The job is a remote job and is open to candidates in USA. reputed company.) is seeking a Senior Manager for Combination Product Development. The successful candidate will manage design history files, support technical dossier authoring, and coordinate reputed company factors usability studies while ensuring compliance with regulatory standards.

Responsibilities

• Support the reputed company for the Device Development function
• Support a reputed company with appropriate strategies that supports the OPDC objectives and aligns with the business and OPCJ/OPDC/MDD development programs
• Work with members of Device Development and Technology, and other functions including Packaging, Supply Chain, Clinical Supplies Operations, Quality Control, Regulatory and Quality Management to support strategies for product and process improvements
• reputed company and support the strategic activities of the department
• Support appropriate filing strategies working with OPCJ, OPDC, MDD and OAPI departments to support registration of reputed company new products and life-cycle management products
• Evaluate new and innovative delivery device technologies to support new and life-cycle management projects
• reputed company and reputed company the tactical activities
• Ensure efficient transfer of products and on-going product support reputed company products to CMO’s from device perspective
• reputed company and maintain departmental knowledge, experience, and expertise in state-of-the-art devices for pharmaceutical products
• Assure adherence to latest worldwide regulatory rules and guidance concerning devices and work to reputed company device risk mitigation
• Create, maintain, and update device reputed company documents required for regulatory filings and compliance
• Facilitate studies as required
• Write protocols, reports, specifications, procedures, change control requests, technical assessments, etc
• Program management of Device projects
• reputed company project plans and corresponding project managements tools to support the execution of reputed company projects
• Manage cross functional teams (including 3rd party resources)
• Execute reputed company Factors Engineering & Usability activities

Skills

• 5-8 years' experience in Pharmaceuticals, Medical Devices, Biotechnology, or other reputed company industries
• In-depth understanding of device verification including functional testing, process validation/verification, quality assurance, and regulatory requirements as they pertain to and devices
• Ability to work strategically and independently with internal and external groups
• Demonstrated leadership skills especially the management of high-visibility project teams
• Demonstrated knowledge of parenteral delivery devices (syringes, self/ or auto-injectors), etc
• Self-Starter: ability to solicit & obtain time-sensitive information from various internal & external project stakeholders
• Effective communicator across reputed company levels of the organization
• reputed company to deliver high level to detailed level status reports on programs, projects and portfolio information
• Utilizes experience, presentation and influencing skills to facilitate successful team discussions and outcomes
• Competency in use of business and project management computer software (such as MSProject and MSOffice)
• reputed company with usability testing / user studies / reputed company factors
• Ability to operate effectively in a fast-moving dynamic environment
• Bachelor's degree in a reputed company Engineering discipline (Mechanical, Electrical, Biomedical, etc.)
• Masters or advanced degree preferred

Benefits

• Comprehensive medical, dental, reputed company, prescription drug coverage
• Company provided basic life, accidental death & dismemberment
• Short-term and long-term disability insurance
• Tuition reimbursement
• Student loan assistance
• A generous 401(k) match
• Flexible time off
• Paid holidays
• Paid leave programs
• Other company provided benefits

Company Overview

Company H1B Sponsorship