Senior RA Associate Consultant

ClinChoice

. Collaborate with the regulatory project team to review, update, and create Technical Documents in accordance with EU MDR and applicable regulatory requirements .

Posted 11/4/2026contractRemote • MexicoSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in EU MDR and global medical device regulatory requirements, with a strong focus on drafting and reviewing Technical Documents. Proficient in quality control processes and effective communication within cross-functional teams.

Highest-signal resume keywords

EU MDR ExpertiseRegulatory Affairs ExperienceTechnical Document CreationQuality Control ChecksMicrosoft Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Technical Document CreationRegulatory Requirements IdentificationQuality Control ChecksDocument Revision ManagementSubmission Expectations Understanding

Soft Skills

Strong Organizational SkillsAttention to DetailPlanning SkillsEffective CommunicationTeam Collaboration

Tools & Technologies

Adobe PDFPLM SystemsMicrosoft Office

Industry Keywords

EU MDRISO13485FDA Medical Device RegulationsRegulatory Project ManagementHarmonized Standards

About the role

Key responsibilities & impact

Collaborate with the regulatory project team to review, update, and create Technical Documents in accordance with EU MDR and applicable regulatory requirements
Establish and maintain understanding of EU MDR and global medical device regulatory requirements
Identify applicable regulatory requirements, harmonized standards, guidance documents, and submission expectations
Draft, create, and update Technical Documents with the Platform RA SME
Review, obtain, and combine TF/DD documents into Adobe PDF files
Create and upload bookmarks and indexes of Adobe PDF files into PLM via Change Orders
Perform quality control checks for completeness, pagination, blank or missing pages, and current document revisions
Work with cross-functional teams and local affiliates to obtain supporting documents
Respond to local affiliate inquiries and coordinate health authority-related questions or requests
Represent Regulatory Affairs on project teams and report regulatory requirements
Attend meetings and communicate with the project team
Communicate project status and deliverables to regulatory management
Support other regulatory activities as assigned

Requirements

What you’ll need

Bachelor’s degree (life sciences preferred)
Minimum of 2 years of working experience in Regulatory Affairs focused on EU MDR
Knowledge of EU MDR, ISO13485, and FDA Medical Device regulations is mandatory
Working proficiency in Microsoft Office (e.g., Word, Excel, PowerPoint)
Ability to work in team environments and on projects of diverse scope with minimal supervision
Strong organizational skills, attention to detail, planning, and communication skills
Strong written and verbal English communication skills

Benefits

Comp & perks

Professional development
Supportive culture
Continuous training
Diversity and inclusivity
Equal opportunity employment