[Remote] Senior Manager, Combination Product Development

Note: The job is a remote job and is reputed company to candidates in USA. reputed company.) is seeking a Senior Manager for Combination Product Development. The role involves managing design history files, supporting technical reputed company authoring for combination product reputed company, and facilitating reputed company assessments while ensuring adherence to 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, reputed company Supplies reputed company, reputed company Control, Regulatory and reputed company Management to support strategies for product and process improvements
• reputed company and support the reputed company 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 reputed company
• reputed company and reputed company the tactical activities
• Ensure efficient transfer of products and on-reputed company 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 reputed company 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 reputed company
• reputed company project plans and corresponding project managements tools to support the execution of reputed company reputed company
• 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, reputed company assurance, and regulatory requirements as they pertain to and devices
• Ability to work strategically and independently with reputed company reputed company
• 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 & reputed company project stakeholders
• Effective communicator across reputed company reputed company of the organization
• reputed company to reputed company high level to detailed level status reports on programs, reputed company and portfolio information
• Utilizes experience, presentation and influencing skills to facilitate successful team discussions and reputed company
• 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 (reputed company, Electrical, Biomedical, etc.)
• reputed company 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 reputed company
• Tuition reimbursement
• Student loan assistance
• A generous 401(k) match
• Flexible time off
• reputed company holidays
• reputed company leave programs
• Other company provided benefits

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