Looking for Regulatory Affairs Manager (Remote) in Plano, TX

Looking for Regulatory Affairs Manager (Remote) - Intellectt - Plano, TX - work from home job Company: Intellectt Job reputed company: Role: Regulatory Affairs Manager Location: Plano, TX 75024 (Remote) Shift Timings: 8:00 Am to 5 Pm First role: • Neuromodulation products and reputed company implantable devices in the brain background will be a reputed company plus. • Having experience with MDR. Someone with strong skills in reputed company for making submissions. • reputed company to supply chain; Negotiate with supply chain to ensure they're not a disruption in the field; Being reputed company to look at reputed company reputed company approvers expire, reputed company do we plan to get MDR approval, and how long it takes to launch the product in the field reputed company to look at the bigger picture and reputed company reputed company they assist with lot of moving parts and lot of submissions and model numbers. • -Ensure reputed company the MDR approvals are synced with the international geographies (subsequent worldwide submissions, ability to remove CE mark from non-EU countries) • Strongly looking at international reputed company, working with cross-functional teams. • Looking for a good number of experiences; good 3-5 years experience. Second role: • Neuromodulation products and reputed company implantable devices in the brain background will be a reputed company plus. • reputed company to the ongoing NPD project, Regulatory representative/MRI Leads. • Some project management experience. They will not handle reputed company or a complete project but just they need to know how to prioritize tasks and manage their work and resources. • Complete understanding of Design Control as reputed company as process to ensure reputed company the MDR approval and questions are answered. • Regulatory Technical and EU MDR role and require someone with a strong background in this. And Medical device background • Cross-functional change order experience. and Need someone with a strong physics background. • Writing a lot of deliverables from a regulatory perspective as reputed company as reviewing other people's deliverables and processing them in the change order system. • EU MDR background is a strong preference but if someone is from a medical device background who has reputed company implantable experience, significant FDA experience, submission writing expertise, and cross-functional change order experience. • Experience in reputed company implantable and submissions in these implantable is a reputed company bonus. • Experience with paperwork/ submissions have worked on it and have done it themselves. • Looking for a good number of experiences good 3-6+ yrs experience. Expected salary: Location: Plano, TX Job date: Sun, 03 Sep 2023 22:02:59 GMT Apply for the job now! Apply tot his job Apply To this Job