Regulatory and Start Up Specialist - Medical Devices - Home-based in Spain

PharmiWeb.jobs : Global Life Science Jobs; Madrid; A distancia; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading global life sciences job provider seeks a Regulatory and Start Up Specialist for a home-based role in Spain. You will be responsible for site activation activities, ensuring compliance with regulatory guidelines and project management tasks. Ideal candidates possess a Bachelor’s degree in life sciences and fluency in Spanish, along with relevant clinical research experience.

Formación

• Minimum 2 years clinical research or relevant experience in submissions.
• In-depth knowledge of clinical systems and procedures.
• Ability to apply GCP / ICH and regulatory guidelines.

Responsabilidades

• Perform site activation activities according to regulations and SOPs.
• Serve as the Single Point of Contact (SPOC) for assigned studies and sites.
• Prepare site regulatory documents and maintain project timelines.

Conocimientos

Regulatory knowledge

Site Activation experience

Spanish language fluency

Educación

Bachelor’s Degree in life sciences or a related field

Descripción del empleo

Regulatory and Start Up Specialist - Medical Devices - Home-based in Spain

Join to apply for the Regulatory and Start Up Specialist - Medical Devices - Home-based in Spain role at PharmiWeb.jobs : Global Life Science Jobs

Regulatory and Start Up Specialist - Medical Devices - Home-based in Spain

1 day ago Be among the first 25 applicants

Join to apply for the Regulatory and Start Up Specialist - Medical Devices - Home-based in Spain role at PharmiWeb.jobs : Global Life Science Jobs

Get AI-powered advice on this job and more exclusive features.

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.

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.

Home Based role requiring submissions experience with MD / IVD and Spanish language fluency.

Essential Functions

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
• Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
• Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines.
• Ensure monitoring measures are in place and implement contingency plan as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

Qualifications

Bachelor’s Degree in life sciences or a related field and 2 years plus clinical research or other relevant experience in submissions.

In-depth knowledge of clinical systems, procedures, and corporate standards.

Knowledge and ability to apply GCP / ICH and applicable regulatory guidelines.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Seniority level

• Seniority level Entry level

Employment type

• Employment type Contract

Job function

• Job function Legal
• Industries Staffing and Recruiting

Referrals increase your chances of interviewing at PharmiWeb.jobs : Global Life Science Jobs by 2x

Sign in to set job alerts for “Regulatory Specialist” roles.

Madrid, Community of Madrid, Spain 2 weeks ago

Madrid, Community of Madrid, Spain 2 weeks ago

Regulatory Compliance and Liaison Specialist - Cybersecurity

Getafe, Community of Madrid, Spain 1 week ago

Madrid, Community of Madrid, Spain 2 weeks ago

Madrid, Community of Madrid, Spain 1 week ago

Senior Specialist, Regulatory & Pharmacovigilance

Madrid, Community of Madrid, Spain 1 week ago

Madrid, Community of Madrid, Spain 2 weeks ago

Arganda del Rey, Community of Madrid, Spain 1 week ago

Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV / LCPRA) - English & Spanish

Madrid, Community of Madrid, Spain 1 week ago

Madrid, Community of Madrid, Spain 21 hours ago

RASSU) Regulatory Affairs Study Start Up Specialist II

Madrid, Community of Madrid, Spain 2 months ago

Regulatory and Start Up Specialist - Medical Devices - Home-based in Spain

Madrid, Community of Madrid, Spain 2 weeks ago

Madrid, Community of Madrid, Spain 5 days ago

Madrid, Community of Madrid, Spain 22 hours ago

Global Quality Regulatory API Specialist

Madrid, Community of Madrid, Spain 7 months ago

Local Contact Person for Pharmacovigilance and Regulatory Affairs (LCPPV / LCPRA) - English & Spanish (French is also preferred)

Madrid, Community of Madrid, Spain 1 week ago

Legal Specialist in Labour Law and Privacy

Tres Cantos, Community of Madrid, Spain 1 week ago

Greater Madrid Metropolitan Area 3 days ago

RASSU) Regulatory Affairs Study Start Up Specialist II

Greater Madrid Metropolitan Area 5 days ago

Process and Quality Specialist (PQS) - Madrid

Madrid, Community of Madrid, Spain 22 hours ago

Madrid, Community of Madrid, Spain 3 weeks ago

Regulatory Affairs Specialist, EMEA RA Support (6 months fixed-term)

San Agustín del Guadalix, Community of Madrid, Spain 4 weeks ago

Madrid, Community of Madrid, Spain 2 weeks ago

Manager Regulatory Affairs Process, Data, Compliance EMEA

Madrid, Community of Madrid, Spain 1 week ago

Madrid, Community of Madrid, Spain 6 days ago

Quality Specialist (Pharmacovigilance and Drug Safety)

Madrid, Community of Madrid, Spain 3 weeks ago

Madrid, Community of Madrid, Spain 5 days ago

RISK ESG Senior Regulatory and Program Implementation expert BNP PARIBAS

Madrid, Community of Madrid, Spain 4 days ago

Head of Compliance & Regulatory - Gibraltar

Madrid, Community of Madrid, Spain 1 week ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

J-18808-Ljbffr