Sr/ Regulatory Affairs Associate- CONSULTANT

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 12 months Contract with 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 supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. Job Title: Sr. Regulatory Affairs Associate- CONSULTANT Location: Mexico - Remote: Must be available 2-3hrs during PST (Pacific Standard Time) business hours Responsibilities: • Actively collaborate with the client’s regulatory project team to collect all necessary TF/DD documents for resubmission. The high-level activities may include but are not limited to: • Establish and maintain an understanding of EU MDR and other global medical device regulatory requirements • Identification of 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 client’s procedure/training/checklist, e.g., verify all pages are present, no blank pages, etc. • Verify TF/DD documents are approved and contain the most recent revision(s) • Work with the local affiliates to respond to queries and obtain necessary legal documents (e.g., Certificate to Foreign Government (CFG), Certificate of Free Sale (CFS), and/or supporting documents from projects) • Notify and coordinate with the leadership of any health authority related questions • 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 • Communicate daily or weekly with regulatory management team regarding project status and deliverables Minimum Requirements: • Bachelor’s degree (life sciences preferred) • Minimum of 1 year of working experience in Medical Device Regulatory Affairs/ training in Regulatory Affairs focused on EU MDR • Basic knowledge of FDA Medical Device regulations, ISO13485, EU MDD/MDR • Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint) • Strong proficiency in written and verbal English communication is required Key Words: Regulatory Affairs, Regulatory Compliance, EU MDD/MDR #LI-PB1 #LI-REMOTE Original job Sr/ Regulatory Affairs Associate- CONSULTANT posted on GrabJobs ©. To flag any issues with this job please use the Report Job button on GrabJobs. Apply tot his job Apply tot his job