Katalyst Healthcares and Life Sciences
Senior Regulatory Affairs Specialist
Katalyst Healthcares and Life Sciences, Omaha, Nebraska, us, 68197
Responsibilities:
The Senior Regulatory Affairs Specialist recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and submission types. Working under general supervision, they contribute to complex strategies, support audits, and guide junior team members. The role also manages change activities for sustaining products, ensuring regulatory partners are informed of key updates. Serve as RA Representative on project teams, develops regulatory submission strategies for new product launch, and provides regulatory guidance to the project teams. Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA, EU and other worldwide government agencies. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability. Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission approval. Maintain regulatory documentations to support compliance with regulatory requirements. Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. Requirements:
You've acquired 5+ years of experience in the medical device regulatory affairs and/or quality assurance field. Experience authoring US 510k and EU MDR Tech Files required. Your skills include knowledge of quality system requirements and FDA and/or international product approval process, demonstrate a track record in obtaining FDA clearances and worldwide registrations, clinical trials and software development/regulatory submissions and authoring 510K's. You have a bachelor's degree or higher in a related field. This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.
The Senior Regulatory Affairs Specialist recommends process improvements, updates regulatory SOPs, and applies broad regulatory knowledge to support compliance across various geographies and submission types. Working under general supervision, they contribute to complex strategies, support audits, and guide junior team members. The role also manages change activities for sustaining products, ensuring regulatory partners are informed of key updates. Serve as RA Representative on project teams, develops regulatory submission strategies for new product launch, and provides regulatory guidance to the project teams. Responsible for coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA, EU and other worldwide government agencies. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability. Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission approval. Maintain regulatory documentations to support compliance with regulatory requirements. Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations. Requirements:
You've acquired 5+ years of experience in the medical device regulatory affairs and/or quality assurance field. Experience authoring US 510k and EU MDR Tech Files required. Your skills include knowledge of quality system requirements and FDA and/or international product approval process, demonstrate a track record in obtaining FDA clearances and worldwide registrations, clinical trials and software development/regulatory submissions and authoring 510K's. You have a bachelor's degree or higher in a related field. This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.