Senior Regulatory Affairs Specialist Jobs in Minnetonka, MN

Advance regulatory strategies for global CMC submissions, managing cross-functional collaboration and internal processes to meet compliance with health authority standards, while leveraging strong com...

Lead the charge in global post-market surveillance by overseeing deliverables, providing team leadership, and ensuring regulatory compliance for medical devices. Engage in strategy, analysis, and cros...

Lead the charge in ensuring continuous regulatory compliance and inspection readiness for R&D technology solutions by executing audit readiness strategies, embedding GxP compliance, and collaborating...

Analyze and drive regulatory CMC strategies for investigational and commercial products, collaborating with cross-functional teams to ensure compliance and success in a dynamic biotech environment. Yo...

Drive quality improvements and ensure compliance across biologic therapeutics by executing medium complexity projects, managing supplier processes, and developing robust quality systems that enhance p...

Partner with us to innovate and transform Quality & Regulatory operations through technology and data analytics. Drive automation, improve efficiency, and foster effective digital solutions that enhan...

Join a team that drives regulatory excellence for clinical development, ensuring strategic and compliant submissions. Collaborate cross-functionally to accelerate drug approval processes while oversee...

Champion regulatory excellence by overseeing compliance and managing the Regulatory Affairs team. Drive strategies for clinical operations while ensuring adherence to FDA guidelines and GCP standards...

Accelerate clinical trial success by optimizing monitoring strategies and processes for efficient, quality data management in alignment with regulatory standards and timelines...

Join a team that's shaping the future of global regulatory strategy. Your expertise will drive compliance, oversee submissions, and lead a dynamic regulatory team in executing key strategies for produ...

Take ownership of regulatory affairs operations, leading teams to enhance processes within clinical trials while ensuring compliance with regulations and fostering collaboration across departments...

Champion the administration and optimization of laboratory systems, ensuring seamless deployment, validation, and integration of informatics solutions within a GMP environment to enhance data integrit...

Manage clinical studies to ensure compliance with regulations and human subject protection. Coordinate site monitoring and maintain quality standards while communicating effectively with site teams to...

Deliver end-to-end bioprocess solutions by leveraging deep expertise in biopharmaceutical workflows, guiding complex customer collaborations, and driving high-impact project leadership for long-term s...

Join a team that's advancing nuclear engineering through component qualification, structural analysis, and seismic qualification for new and existing facilities. Collaborate with multidisciplinary exp...

Join a team that's shaping global regulatory strategies for innovative medical devices, ensuring compliance and excellence in quality assurance while leading cross-functional collaborations to deliver...

Transform global regulatory processes by leading approvals, strategizing submissions, and ensuring compliance for medical devices across diverse markets while collaborating with teams and serving as a...

Manage global regulatory strategies for clinical and commercial product registrations. Ensure compliance and successful market access for the PSMA franchise. Lead cross-functional collaborations and d...

Drive impactful marketing campaigns through creative oversight and strategic management. Collaborate with cross-functional teams to enhance digital initiatives, optimize performance, and support organ...

Unlock potential by guiding global regulatory strategies for innovative AI/ML healthcare solutions. Collaborate cross-functionally to navigate complex regulations while balancing innovation and patien...

Contribute to lead risk-based quality management for oncology trials across phases. Collaborate with cross-functional teams to assess risk, ensure data quality, and drive mitigation. Provide expert gu...

Join a team that's driving compliance excellence in supply chain operations. This role blends collaboration across Contracts, Legal, and Supply Chain, focusing on government contracting and ensuring r...

Join a team that's dedicated to enhancing clinical trial quality through leadership, mentorship, and oversight. Engage remotely with cross-functional teams, driving high standards for patient safety a...

Join a team that's dedicated to advancing medical device compliance by applying your expertise in IEC 60601 standards. Collaborate across functions to drive safety and quality in new product developme...

Manage reimbursement strategies supporting business goals across product areas. Collaborate with teams to guide product development, analyze landscapes, and educate stakeholders on reimbursement impac...