Sr. Regulatory Affairs Associate- Consultant

hace 3 semanas

Xico, México Clinchoice A tiempo completo

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring?Our team says it's the best of both worlds....ClinChoice is searching for a Senior Regulatory Affairs Associate Consultant for a 12-month contract with the possibility of extension to join one of our clients.ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and a supportive culture.As a client-facing role, we are looking for confident candidates who can work independently while establishing a high-trust environment with the client's counterparts.Job TitleSenior Regulatory Affairs Associate ConsultantLocationMexico – RemoteResponsibilitiesActively collaborate with the client's regulatory project team to collect all necessary TF/DD documents for resubmission.Establish and maintain an understanding of EU MDR and other global medical device regulatory requirements.Identify applicable regulatory requirements, standards, guidance, and submission requirements relevant to the project.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 per the client's procedures/training/checklist (e.G., verify all pages are present, no blank pages).Verify TF/DD documents are approved and contain the most recent revisions.Work with local affiliates to respond to queries and obtain necessary legal documents (e.G., Certificate to Foreign Government (CFG), Certificate of Free Sale (CFS), and supporting documents from projects).Notify and coordinate with leadership regarding any health-authority related questions.Represent Regulatory Affairs on project teams and report regulatory requirements in the required frequency, format, and sequence.Attend meetings and communicate with the project team as appropriate.Communicate daily or weekly with the regulatory management team regarding project status and deliverables.Minimum RequirementsBachelor's degree (life sciences preferred)Minimum of 1 year of experience in Medical Device Regulatory Affairs or training in Regulatory Affairs focused on EU MDRBasic knowledge of FDA MedTech regulations, ISO, and EU MDD/MDRProficient in Microsoft Office (e.G., Word, Excel, PowerPoint)Strong written and verbal English communication skills are requiredPreferred QualificationsTraining in EU MDD/MDR#J-*****-Ljbffr

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