1MED SA, Contract Research Organization that provides clinical and regulatory services to medical device, in vitro diagnostic, pharmaceutical companies  is hiring.

Are you a dynamic person, interested in an innovative and smart approach to clinical research with focus on the medical device field? What an exciting time to come on board: together with our clinical team you will be supporting MedTech companies in seeking and maintaining compliance to the new Medical Device Regulation 2017/745 requirements, generating strong and supportive clinical data with reference to medical device’s specific claims.

We are looking for a Senior Regulatory & Start-up Specialist with at least 3 years of experience in the field to join our team!

Role with high career development opportunities.

To join us in this exciting new venture, please contact us!

Senior Regulatory & Start-up Specialist – Key Responsibilities

– Work self-sufficiently and proactively to coordinate all necessary activities for Competent Authority (CA) & Ethics Committee (EC) submissions and approvals and collaborate to the essential document collection for allocated clinical research sites

– Manage multiple sets of essential regulatory documens across several studies and therapeutic indications

– Develop and foster clinical research site relationships to become a subject matter expert in the site start up regulatorty process across multiple studies

– Leverage knowledge of sitet regulatory processes to meet clinical study goals and objectives

– Manage and problem solve site start up challenges that arise to mitigate impact to study goals

– Identify and escalate issues before they become critical

– Develop, prepare, complete and track required regulatory, ICF and legal documentation, compiling Core Document Dossier/RA/IEC/IRB Submission Package

– Review, prepare and negotiate site contracts and budges with sittes, if required

– Document clinical research site and investigator readiness for participation across multiple studies

– Support internal quality audits, regulatory inspecions, as applicable

– Update and maintain study-specific start-up trackers

– Ensure compliance with appropriate regulatory (ICH/GCP, ISO, CA, EC, ec.) and internal SOPs/WI, policies & procedures

Senior Regulatory & Start-up Specialist – Qualifications

– At least 3 year in a similar position

– Significant clinical Start-up/Site Activation experience in a sponsor/CRO

– Previous experience working with clinical trial managemen systems and clinical document control systems / eTMF

Senior Regulatory & Start-up Specialist – Skills

– Ability to muli-task: support several studies and/or personnel simultaneously, work in a very fast paced environment

– Ability to work in a team environment and possess clear, concise communication & presentation skills – Procifiency both in English (written and spoken)

– Proficiency in English (written and spoken)

– Must be comfortable interacting with clinical research site personnel via phone, email, and in person

– Demonstrated ability to establish credibility internally and externally by commanding knowledge of informed consent requirements

Apply to our open position and join us in this exciting new venture, becoming part of the 1MED team!