The Montgomery County Correctional Facility constitutes a critically essential operating element of the Montgomery County Criminal Justice System. Its operation is directed by federal, state, county laws, standards and regulations. Montgomery County Correctional Facility staff is responsible for the overall operation of its facility, including security, enforcement of est

The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requires working knowledge of products under review and of relevant regulations and guidance documents. This i

Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitor

The Compliance Manager works with the Director of Compliance and Chief Compliance Officer to support our Global business on compliance matters relating to adherence to relevant policies, codes, laws, and regulations impacting business operations. The Compliance Manager will assist with various aspects of our compliance program, including compliance training, auditing and

SHIFT Day (United States of America) Seeking Breakthrough Makers Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation. At CHOP, your experience is valued; your voice is heard; and your contributions make a

The Lead Regulatory Affairs Specialist leads the preparation of document packages for regulatory submissions for new and sustaining enhanced technologies, software enabling and robotics systems within the Surgical Intelligence (SI) portfolio, to ensure compliance with local and regional registration requirements. The Lead Specialist will be responsible for coordinating pr

Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitor

SHIFT Day (United States of America) Seeking Breakthrough Makers Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation. At CHOP, your experience is valued; your voice is heard; and your contributions make a

Senior Regulatory Affairs Associate Experience Biologic CMC 5+ years of experience Supported the CMC activities related to Vaccine/Biologic manufacturing and control including authoring of submission dossiers related to new application, post approval variations Understanding of EU/CA/WHO/US regulations & guidance allowing appropriate review and compilation of data to appr

We are recruiting for experienced Regulatory Affairs Professionals on various levels. In this role, you will focus on clinical trial submissions. We are looking for someone who is experienced in CTA, EU CTR knowledge and experience would be a strong plus. The role can be based in our office in Madrid or remote. Key Deliverables in the role Manage the local submissions (as

include Works individually and as a team to engage with potential and active program participants Assists during direct service delivery to facilitate participant flow and throughput Assists program participants both during direct service delivery and telephonically in identifying personal recovery goals, assisting in setting objectives for each goal, and determining inter

Local submission of CTA according to the EU directive until the end of the transition period in Belgium, France, Luxembourg and Monaco, then submission according to EU CTR Local submission of MAP and NIS Education Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree Preferred Language skills Must be fluent in French and Englishcommunicat

Regulatory Affairs Consultant must have an understanding of the organization's consulting models and methodologies, as well as good knowledge of what services PC provides. The Consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. This key role in the organization ensures the timely performance of wo

Supervise a team of front line QC Scientists. Performs administrative duties, i.e. hiring, performance management and supporting your team's development goals Schedules and assures adherence to schedule for the performance of analytical testing for biochemical analysis, so that all testing to support the production and release of product lots is performed in compliance wi

Deliver/Lead specific Systematic Literature Review project steps e.g. screening, extraction, protocol design, quantitative feasibility. Understands project specific requirements to customize deliverables per specifics and apply innovative evidence presentation strategies. Develops project deliverables as required in a typical Systematic Literature Review project e.g., sys