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 description: Role: Regulatory Affairs Manager Location: Plano, TX 75024 (Remote) Shift Timings: 8:00 Am to 5 Pm First role: • Neuromodulation products and active implantable devices in the brain background will be a huge plus. • Having experience with MDR. Someone with strong skills in strategy for making submissions. • Related to supply chain; Negotiate with supply chain to ensure they're not a disruption in the field; Being able to look at when current approvers expire, when do we plan to get MDR approval, and how long it takes to launch the product in the field Able to look at the bigger picture and make sure they assist with lot of moving parts and lot of submissions and model numbers. • -Ensure all 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 strategy, working with cross-functional teams. • Looking for a good number of experiences; good 3-5 years experience. Second role: • Neuromodulation products and active implantable devices in the brain background will be a huge plus. • Related to the ongoing NPD project, Regulatory representative/MRI Leads. • Some project management experience. They will not handle a team 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 well as process to ensure all 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 well 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 active implantable experience, significant FDA experience, submission writing expertise, and cross-functional change order experience. • Experience in active implantable and submissions in these implantable is a huge 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