Essential Functions : Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Maintains company registrations and device listings in the US, Canada, and the EU. Analyzes and reports department metrics. Supports
Position Summary Provides regulatory support and expertise associated with global and US registration of medical device products, including in-depth analysis of the requirements and tracking of deliverables. With oversight, supports creation of global regulatory strategies and assists in
At Alcon, were passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing
At Alcon, were passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing
Company Description About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on
Job DetailsJob Location: HB - Huntington Beach, CA 92647Salary Range: $25.00 - $25.00 HourlyABOUT AIRTECH:Airtech is a family-owned, community focused, global leader founded in 1973. We are the market leader in materials used in the manufacturing
At Alcon, we’re passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates worldwide, we innovate fearlessly, champion progress, and act with speed to advance global eye health. At Alcon, you’ll be
At Alcon, were passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing
Documentation Specialist Location: Remote (Must be local to Irvine, CA and able to come onsite as needed) Duration: 2-Year Contract (with potential extension based on performance and business needs) CA RATE: $23-$28/HR Orion Group is seeking a
Regulatory Affairs Specialist (FDA, DEA) The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOns pharmacy, manufacturing, and healthcare operations meet all applicable regulatory requirements. This position is responsible for preparing submissions, maintaining licenses, coordinating audits, and staying ahead of
Principle Regulatory Affairs Strategy Associate The Principle Regulatory Affairs Strategy Associate, reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for setting or executing the regulatory strategy, leading and managing, acting as a strategist, ensuring local product
Regulatory Strategy Lead Execute on regulatory strategy of De Novo submissions for AI/ML-based Software as a Medical Device (SaMD) product, including AidaBreast. Serve as regulatory lead for novel oncology diagnostic technologies integrating genomic and proteomic biomarkers. Ensure alignment with
Compliance Testing Analyst Position at loanDepot Position Summary: Responsible for supporting the execution and continuous enhancement of the companys compliance testing program, with a primary focus on mortgage originations and servicing activities. This role will be
Job Title Responsibilities: Support the Senior Director in developing and executing regional regulatory strategies for QOL initiatives within specific regions. Contribute to providing strategic oversight and leadership to the regulatory team, ensuring alignment with company objectives and regional
Regulatory Affairs Specialist Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government and
Sr. Associate II, Regulatory Affairs Strategy At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye
Join Alcon At Alcon, were passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates worldwide, we innovate fearlessly, champion progress, and act with speed to advance global eye health. At Alcon,
Join Alcon At Alcon, were passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates worldwide, we innovate fearlessly, champion progress, and act with speed to advance global eye health. At Alcon,
Regulatory Affairs Manager In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU
Principle Regulatory Affairs Strategy Associate The Principle Regulatory Affairs Strategy Associate, reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for setting or executing the regulatory strategy, leading and managing, acting as a strategist, ensuring local product