Regulatory Affairs and Site Activation Specialist

**Regulatory Affairs Specialist** - Develop and maintain regulatory strategies for the development, registration, and commercialization of **medical devices**: - Communicate with regulatory authorities to obtain timely approvals for medical devices - Review and approve labeling, marketing, and promotional materials to ensure compliance with regulations -...

**Job Overview** Under general supervision, perform tasks at a country level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. **Essential Functions** - Under...

**Job Description**: Trial Activation Approval Specialist I Essential Functions and Other Job Information: Essential Functions - Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy. - Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global...

**Job Description**: Trial Activation Approval Specialist I - Essential Functions and Other Job Information: - Essential - Functions- Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy.- Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with...

In the context of a new project, we are looking for a Regulatory Affairs Specialist to join our teams in Mexico/LATAM. Responsibilities Provide guidance and support about Mexican and Central America legislation Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal...

**Ubicación MEXICO, MEXICO CITY** ¿Está buscando una empresa que se preocupe por la vida y la salud de las personas, incluida la suya? Inspiremos vidas más saludables, juntos **Olympus, una empresa líder en tecnología médica, se ha centrado en mejorar la vida de las personas durante más de 100 años.** **Nuestro propósito es hacer que la vida de...

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the centre of all that we do, we help to accelerate the development...

**Requisition Number**7930** **Employment Type**:Regular** **Who we are** We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and...

Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general supervision, serve...

Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions • Under general supervision,...

**Description** **Site Activation Manager II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our...

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to...

**JOB DESCRIPTION** **PURPOSE** Perform tasks at country level associated with Regulatory, Start-up (RSU) and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May participate in feasibility and/or site identification...

Regulatory Affairs Analyst (Fixed Term) page is loaded Regulatory Affairs Analyst (Fixed Term) Postuler locations Mexico City, Mexico time type Temps plein posted on Offre publiée hier job requisition id R5646189 Viatris Healthcare México S. de R.L. de C.V Chez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait...

Who we are We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a...

Start-up & Regulatory Specialist page is loaded Start-up & Regulatory Specialist Apply locations Mexico City Mexico time type Full time posted on Posted 30+ Days Ago job requisition id 2412781 As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides...

**Description** **Job Description**: JOB TITLE: Site Start-Up & Regulatory Specialist II SELECT ONE: Clinical Solutions JOB CODE: 01022 REPORTS TO: Manager, Site Start-Up & Regulatory; or designee JOB SUMMARY Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. Responsible for...

Responsible for coordinating, preparing, and maintaining regulatory submissions and documents on a global level for Europe, the United States, and other countries. Primary responsibilities are to ensure regulatory compliance for assigned product lines Other responsibilities include coordinating recalls, identifying relevant standards and guidance documents...

The legal team protects Red Bull, its people, partners and vendors by adding value to each product line and initiative. Legal is divided into Legal Business Partners for the Beverage Business and Corporate Projects, Specialist Departments and Centers of Expertise. The Regulatory Specialist assists the LATAM Regional team by offering technical and legal...

In the context of additional activities for one of our main clients, we are looking for a Regulatory Affairs Officer working from Mexico or Canada to manage post-MAA activities (Life Cycle Management) for the Canadian market. Responsibilities Management of post approval activities (Life Cycle Management) for the Canadian market Initiate change...