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Sr. RA Associate Consultant

ClinChoice
Contract type
Freelance
Work mode
Remote · Mexico
Experience
Mid-level · 2+ years

Job description

A 12-month consultant contract (with possibility of extension) as a Sr. Regulatory Affairs Associate, working directly for one of ClinChoice's clients. The role focuses on reviewing, updating and creating Technical Documents in line with EU MDR and other medical device regulatory requirements.

At a glance

Employment
Contract · Independent contractor
Work mode
Remote · Mexico
Languages
English

What you'll do

  • Establish and maintain an understanding of EU MDR and other global medical device regulatory requirements
  • Identify applicable regulatory requirements, harmonized standards, guidance documents, and submission expectations
  • Draft, create or update TDs in collaboration with Platform RA SME
  • Review, obtain, and combine TF/DD documents in PLM or similar regulatory sources into Adobe PDF files
  • Create and upload bookmarks/indexes of the Adobe PDF files into PLM via Change Orders
  • Perform Quality Control checks in accordance with client procedures, training, and checklists, including verification of completeness, correct pagination, and absence of blank or missing pages
  • Verify TD documents are approved and contain the most recent revision(s)
  • Work with the cross functional teams and Company's local affiliates to obtain necessary supporting documents
  • Respond to inquiries from the Company's local affiliates and proactively notify and coordinate with cross-functional teams including management any health authority–related questions or requests
  • Represent Regulatory Affairs on project teams and report regulatory requirements in the frequency, format, and sequence as required
  • Attend meetings and communicate with the project team as appropriate
  • Routinely communicate with regulatory management team regarding project status and deliverables
  • Support other regulatory activities as assigned

What we're looking for

  • 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)
  • Self-starter with ability to work in team environment and projects of diverse scope where analysis of a situation or data requires evaluation of various factors with minimal supervision
  • Strong organizational skills including attention to detail, good planning and communication skills
  • Strong written and verbal English communication skills

How to get hired

  1. 1Submit CV and receive an acknowledgement
  2. 2Phone interview as the first step

Apply

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About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

Mission

To contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

Key facts

  • over 4,000 professionals
  • Contract Research Organization (CRO)
  • Over 28 years of proven high-quality delivery and results across all our services
  • Over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific
  • Below industry average turnover rates

What they value

  • Quality
  • Professional development
  • Supportive culture
  • Diversity and inclusivity