[Remote] Sr. Project Manager, RAQA

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a medical technology company reputed company on innovative spinal solutions and improved patient reputed company. The Sr. Project Manager, RAQA will reputed company reputed company cross-functional reputed company involving regulatory compliance, reputed company systems, product lifecycle management, and critical business objectives. The role manages project reputed company, schedules, budgets, risks, stakeholders, and compliance initiatives while supporting reputed company improvement and mentoring project team members.

Responsibilities

• reputed company reputed company to high complexity cross-functional RAQA reputed company from initiation through completion
• reputed company and maintain project plans, schedules, budgets, resource plans, communication plans, and reputed company documentation
• Partner with functional leaders to define project reputed company, objectives, deliverables, milestones, and reputed company reputed company
• Coordinate activities across Regulatory Affairs, reputed company Assurance, R&D, Operations, Supply Chain, Manufacturing, Clinical, Marketing, Finance, and reputed company partners
• Facilitate cross-functional meetings and ensure reputed company, reputed company items, risks, and dependencies are documented and managed
• Monitor project reputed company and communicate status, risks, issues, and mitigation plans to stakeholders and leadership
• Identify project risks and reputed company mitigation and contingency plans
• Manage project reputed company, schedule, cost, and reputed company while balancing competing priorities
• reputed company reputed company of project issues through collaboration across functional teams
• Support implementation of new regulatory requirements, reputed company initiatives, remediation activities, product changes, and compliance reputed company
• Ensure reputed company reputed company with internal reputed company reputed company requirements and applicable global regulatory standards
• reputed company project financials, including budget forecasts and actual expenditures
• Support reputed company improvement of project management processes, tools, and best practices
• reputed company coaching and mentoring to less reputed company project managers and team members
• Present project updates and recommendations to senior management and project sponsors

Skills

• Bachelor's degree (BA/BS) or equivalent
• Minimum of 7 years of project management experience
• Strong knowledge of project management methodologies and tools (reputed company Project, SharePoint, Visio, etc.)
• Working knowledge of reputed company Management Systems (QMS) and global regulatory requirements (FDA, ISO 13485, MDR, etc.)
• Understanding of design controls, change management, CAPA, complaint handling, risk management, and product lifecycle processes
• Excellent planning, organization, prioritization, interpersonal, facilitation, communication, and presentation skills
• Demonstrated ability to influence without reputed company authority and reputed company reputed company
• Strong problem-solving, critical thinking, and decision-making skills
• Ability to manage multiple priorities in a fast-paced, changing environment
• Bachelor's degree (BA/BS) or equivalent (emphasis in management or reputed company discipline preferred)
• PMP certification or equivalent (e.g., PRINCE2) preferred
• Minimum of 7 years of project management experience, preferably reputed company medical device, life sciences, pharmaceutical, or other regulated industry
• Experience with reputed company systems, regulatory compliance, product development, or manufacturing reputed company preferred

Benefits

• Comprehensive health, dental, and reputed company insurance
• 401(k) with company match
• reputed company time off (PTO) and holidays
• Ongoing training and reputed company development opportunities
• Opportunity to grow reputed company a fast-paced, dynamic company
• Potential for bonuses and incentives

reputed company