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Quality Project Manager -Regulatory

Carl Zeiss Inc Hebron, KY

  • Expired: May 05, 2021. Applications are no longer accepted.

Job Description Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people. We are looking for project manager for North America to support local and global projects to meet Quality and regulatory needs: Under the direction of the VP of global Quality and US FDA Regulatory Affairs Management Officer this position will lead projects by providing broad-based support for all key Quality and Regulatory activities and initiatives.

This includes Quality Systems, new product implementation, continuous improvement projects, product/process auditing with the focus on regulatory requirement fulfillment, compliance with all specifications, process and operational procedures. Ensure that policies are established. Implement established policies, system monitors and controls to ensure the successful management and reporting of all corporate initiatives in the program • Oversee the full project portfolio across multiple business functions, whilst managing individual specific projects also. • Oversee the full project management life cycle for the implementation of, sometimes, highly complex, large-scale, strategic business initiatives. • Implement established policies, system monitors and controls to ensure the successful management and reporting of all corporate initiatives in the program • Oversee the impacts and interdependencies in between programs and working environment to ensure initiatives meet the goals and objectives of the executive leadership team. • Manage project execution to ensure adherence to budget, schedule, and scope. • Develop or update project plans for projects including information such as project objectives, technologies, systems, information specifications, schedules, funding, and staffing. • Monitor or track project milestones and deliverables. • Oversee, review and actively engage into all regulatory topics national (not limited to FDA CFR820, HIPAA) and internationally to cover regulatory and legal requirements of projects in conjunction with the legal and global regulatory team. • Reach out and work with specialized regulatory consultants outside of ZEISS to cover specific regulatory topics on local or global level. • Confer with project personnel to identify and resolve problems. • Develop and manage work breakdown structure (WBS) of projects. • Lead Special Project Teams as assigned • Analyze data to identify trends or relationships among variables. • Provides directions and makes recommendations and decisions on project direction on regulatory and non-regulatory topics, including risk-based thinking. • Provides frequent reports to Project Stakeholders/Steering Committees You should have: • Bachelor’s degree in Business or Related Field, or 5+ Years Equivalent Experience • PMP Certification, or equivalent. • >5 years project management experience required • >5 years of regulatory experience in the medical or similar field and expertise required • Proficient in MS Office, particularly MS Project • Fundamental understanding of manufacturing and business processes desirable • Ability to read basic construction drawings. • Willing to travel domestically and internationally 25-50% of the time • Excellent interpersonal skills • Good verbal and written communication skills • Good listener/receive constructive criticism • Self- starter/leader/motivator • Must be assertive/good decision maker • Able to work flexible hours. • Ability to collect and analyze statistical and technical data. In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together. Join us today.

Inspire people tomorrow. Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity. Apply now! It takes less than 10 minutes. Company Description Carl Zeiss Inc- an internationally leading technology enterprise operating in the fields of optics and optoelectronics. Carl Zeiss Inc- solutions contribute to world optics development and technological progress.

With our passion for excellence, we create value for our customers and inspire the world to see in new ways.

Carl Zeiss Inc


Hebron, KY



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