ClinChoice - Sr. RA Associate Consultant
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) • 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 are required • Strong written and verbal English communication skills required. • The Application Process • Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. • Who will you be working for? • ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. • Our Company Ethos • Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
Responsibilities
• 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 • Perform Quality Control checks per Company’s procedure/training/checklist, e.g., verify all pages are present, no blank pages, etc., 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
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