Responsible for strategic leadership and direction needed to develop, implement and maintain state of the art microbiology and sterilization assurance methods for Smith + Nephew using a well grounded understanding of technical, scientific and regulatory issues.20 % Develops and oversees Global policies, procedure and training related to cleanrooms, sterilization, and reus

Assists designers with the preparation of master plans and site specific designs. Prepares graphics, maps and diagrams to support planning projects. Conducts planning studies to include feasibility students and assists in coordinating Reuse and redevelopment Master Plans Support public outreach and engagement, with an emphasis on equity. Research and interpret land use, z

Develops, maintains and manages all plan fee schedules and code pricing. Monitors multi state regulations including DHHS, EOHHS, and CMS websites, listservs and other sources to identify existing payment practice and proposed changes. Determine the scope and impact of the change on Plan operations and seek to implement changes as necessary. Business owner in managing soft

At Boston Children's Hospital, the quality of our care and our inclusive hospital working environment lies in the diversity of our people. With patients from local communities and 160 countries around the world, we're committed to reflecting the spectrum of their cultures, while opening doors of opportunity for our team. Here, different talents pursue common goals. Voices

We are seeking an experienced Regulatory Generalist to join our FSP team as a Senior Regulatory Affairs Associate / Regulatory Affairs Consultant to work closely with one large, dedicated client and provide operational support in the IND/NDA maintenance stage. The Sr. Associate / Consultant will also provide appropriate regulatory guidance to Project Teams for the develop

Duties WHAT IS THE SMALL BUSINESS SELF EMPLOYED DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas SBSE Small Business/Self Employed, SB/SE Deputy Commissioner Exam, Specialty Examination, Estate & Gift /Excise Tax Exam The following are the duties of this position at the full working level. If this vaca

of Role Responsible for integrating and applying advanced knowledge of global regulations governing pharmaceutical drug development and commercialization to all aspects of assigned preclinical and/or clinical drug development programs, policies, and procedures, to ensure the rapid and successful development and registration of products while maintaining compliance with all

Duties WHAT IS THE LARGE BUSINESS AND INTERNATIONAL (LBI) DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas Large Business and International Director Northeastern Compliance Practice Area (NECPA) The following are the duties of this position at the full working level. If this vacancy includes more than

The Principal Regulatory Specialist is responsible for carrying out Pre Market and Post Market regulatory activities in compliance with Digital Factory's Quality Management System for domestic and various international markets for SaMD products. This role shall provide product level leadership and initiative by independently developing and executing regulatory strategies

Develop, implement, and lead the regulatory regional strategy, in alignment with company goals, for new and sustaining ZOLL Resuscitation products and features. Essential Functions Develop and successfully implement regional regulatory strategies for new and sustaining products/features that result in device approval. Ensure project team colleagues, line management, and k

If you are passionate about innovative therapies, love leading complex regulatory filings, and live for quality, on time, and within budget project deliverables, Parexel is E X P A N D I N G and we currently have openings for Senior Regulatory Affairs Consultants / Regulatory Affairs Leads. These are incredible opportunities to join a tight knit team of amazingly nice and

of Key Responsibilities Provides leadership and guidance to various stakeholders to ensure development and implementation of innovative global regulatory strategies across Alnylam's portfolio of combination/device products Provides technical, strategic and tactical regulatory guidance to matrixed product development teams Defines and optimizes global regulatory strategies

Parexel's Strategic CGMP Compliance team is known for our unparalleled breadth and depth of expertise globally. Parexel CGMP Compliance offers services which create and maximize product value for clients throughout the product lifecycle, leveraging our unique fusion of scientific, regulatory, and business expertise. We are the pre eminent regulatory and GxP (Good Clinical

Duties WHAT IS THE APPEALS DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas Independent Office of Appeals Specialized Exam Programs & Referrals/Area 10/Team 2 The following are the duties of this position at the full working level. Conducts Appeals conferences for the settlement of the largest and most

This is a remote role; the ideal candidate will live in the New England area. The Ragon Institute is a highly unique, innovative, and collaborative research center at the forefront of biomedical science. Founded by Massachusetts General Hospital, MIT, and Harvard, the Ragon vision is a bold one to harness the power of the immune system to prevent and cure human disease on