Prepares /oversees the preparation of various regulatory submissions including Pre Submissions, 510(k) submissions, CLIA Waiver Applications, Dual 510(k)/Waiver by Applications, technical files, and license applications. Monitors new and changing regulations and guidance and disseminates information to stakeholders. Identifies regulatory trends and conducts key regulatory

Review all SpeakUp reports to identify emerging trends and create and implement relevant risk mitigation plans; Conduct or oversee internal investigations for the global organization from intake to closure; Supervise regional compliance investigators and other internal and external compliance resources as they conduct investigations. Advise on and, where appropriate, mana

Top Workplaces 2022 Lake & Pond Technician Benefits Start Day 1 for Full Time Colleagues No Waiting Period! Looking to build your career in an exciting industry and a growing world class organization? Come see why so many of our team members recommend us to their friends! Who are we? SOLitude Lake Management a proud member of the Rentokil family of companies provides aquat

The Trademark Analyst serves as a subject matter expert internally and externally on all trademark matters related to both verbal and visual branding. This role is responsible for screening both name and logo candidates and clearly articulating rationale to internal and client teams. This role is the cornerstone of our VETT process and must be confident in all steps of th

CMC Regulatory Strategy Partner with key stakeholders to develop and implement CMC regulatory strategies and plans for CMC projects. Develop solutions to regulatory or business problems where no clear precedence exists. Submissions for Development and Commercial Products Lead activities, including planning and reviewing US CMC sections of all regulatory submissions (i.e.

Develop solutions to improve processes for global regulatory submissions. Identify, implement, support validation and manage software tools for organizing regulatory files, registration tracking and documentation for submissions Manage Regulatory tools/database and new enhancements. Interact with global regulatory leaders and peers to share and manage department metrics a

A collective energy and ambition. A place where you can make a real difference. We're a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and owner

The IT Business Partner will work closely with Human Resource leaders to maximize the impact of IT capabilities on business performance and ensure IT services meet business needs and objectives.Reporting to the Head of Enabling Functions Business Partner lead, this person will play a critical role to ensure the Human Resource function leverages technology solutions to ach

Consulting Associate Capital Excellence Job ID 87922 Who You'll Work With You will be working with McKinsey's Capital Excellence service line in North America. Our Capital Excellence service line assists our clients in solving the world's toughest problems. Blending strategic thinking with hands on practicality, our team of consultants and experts work to develop and impl

Reviews and interprets regulations/guidance documents to develop regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, IND & CMC strategies, submission requirements, timing and risks. Interact with US FDA and acts as a liason with Corporate International RA and/or country RA to define submission content, expedite pend

The role is a technical lead that requires deep knowledge, skills, and experience in designing and carrying out clinical analytics. The position is a key team member collaborating in a multi disciplinary business environment with colleagues across the enterprise to lead clinical performance analytics, development, and reporting that deliver actionable clinical insights to

Grow the planning practice in the Northeast/New York metro region and mentor staff. Lead business development activities, including developing and networking with clients, preparing planning strategies for proposals and contracts, and supporting regional market leaders in the real estate, institutional, state and local government, transportation, and energy markets. Devel

Manage applications to the FDA for Certificates to Foreign Government (CFG), and Export Certificates. Review, approve and submit FDA invoices, FDA submission check requests and FDA forms. Manage requests for regulatory document apostilles and legalization services. Manage Regulatory calendar for the RA team and leadership. Provide awareness of team meetings, holidays, lea

One of the top strategic priorities of Zoetis is to power our business through digital solutions and data insights. Strong data governance is imperative in order to optimize the value created from our digital and data assets. As such, Zoetis is establishing a Data Governance program to improve the quality and consistency of our data, increase efficiency and productivity o

The role is a technical lead that requires deep knowledge, skills, and experience in designing and carrying out clinical analytics. The position is a key team member collaborating in a multi disciplinary business environment with colleagues across the enterprise to lead clinical performance analytics, development, and reporting that deliver actionable clinical insights to