Site Regulatory & Submission Associate II (EMEA)

Site Regulatory & Submission Associate II (EMEA)
Role Summary
The Site Regulatory & Submission Associate II performs regulatory activities at study startup, maintenance, and
closeout in the assigned EMEA region. The primary focus is the preparation and submission of documents to Ethics
Committees and Competent Authorities, including country- and site-specific Patient Informed Consent adaptations,
with the objective of obtaining required approvals within or ahead of forecasted timelines.
Key Responsibilities
Prepares documents for Ethics Committee/Competent Authority (EC/CA) submission in the assigned region,
including submissions to other national authorities as applicable.
Initiates translation of documents as applicable (e.g., Patient Informed Consent); reviews and adapts translations
to appropriate regulatory and lay terminology.
Prepares country- and site-specific Patient Informed Consent forms in accordance with regulatory and EC
requirements; obtains internal approvals as required.
Interprets clinical study protocols to support EC/CA submission in lay terms.
Serves as point of contact for EC/CA and other national authorities; executes submissions and supports the
approval process including document adaptation and response coordination.
Coordinates responses to EC/CA and other authorities involving relevant internal stakeholders.
Supports budget adaptation to country and site requirements.
Maintains local regulatory documents (paper or electronic) and ensures upload to applicable data management
systems.
Builds and maintains submission intelligence in the assigned region by staying current on MDR, ISO, GCP, and
other national/regional regulatory requirements.
Anticipates potential compliance issues and takes timely action to mitigate risk.
Supports training of internal and external clinical professionals on clinical trial regulations.
Assists with collection of site activation documents and supports Clinical Site Management teams.
May serve as a mentor for new or entry-level team members on functional, process, and regulatory tasks.
Required Qualifications
Bachelor's degree from an accredited university or college, or equivalent experience in clinical research, medical
device/pharmaceutical, or a clinical/hospital environment.
Minimum 5 years of experience in regulatory processes for clinical studies, or an equivalent combination of
education and experience.
Proficiency in submission processes in the assigned region.
Proficiency in MDR/ISO/GCP requirements and other applicable national/regional regulations.
Native fluency in the applicable country language(s), with ability to correspond with laypersons and EC/CA
representatives; English proficiency also required.
Proficiency in Microsoft Word, Excel, or equivalent software; familiarity with clinical data operations reports and
applications.
Proficiency with cardiac, vascular, and/or neuromodulation technologies and clinical research processes.
Demonstrated critical thinking, problem-solving, and professional communication skills (written and verbal).
Ability to manage multiple assignments and milestones concurrently; able to work independently and within a
team.
Strong organizational skills and attention to detail; ability to multitask and meet deadlines in a fast-paced, matrixed
environment.
Preferred Qualifications
Experience working in a cross-division or enterprise business unit model.
Some experience in audit preparation.
Familiarity with FDA regulatory requirements and guidelines.