Senior RA Associate Consultant

🔥 16 hours ago

🇲🇽 Mexico – Remote

⏳ Contract/Temporary

🟠 Senior

💼 Consultant

👻 Ghost score 10%

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ClinChoice

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1998

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ClinChoice is a global full-service contract research organization (CRO) established in 1995, specializing in clinical development, post-marketing, and functional service support for the pharmaceutical, biotechnology, and medical devices industries. They provide comprehensive solutions from early clinical development to post-approval lifecycle management, with expertise in a variety of therapeutic areas such as autoimmune and inflammation, dermatology, endocrinology, infectious diseases, neuroscience, and oncology. ClinChoice aims to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. The company supports its clients with clinical, regulatory, and operational expertise across all phases of product development.

📋 Description

• 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

• 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

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

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