Regulatory Affairs Manager Jobs in Omaha, NE

Drive global regulatory strategy for medical imaging products, ensuring compliance across the software development lifecycle. Lead a dynamic team, engaging with cross-functional partners and regulator...

Shape the future of medical devices by leading regulatory strategies, ensuring compliance across global markets, and mentoring a dedicated team. Empower innovation through effective communication with...

Engage with cross-functional teams to ensure regulatory compliance for Expanded Access Programs. Drive essential strategies and submissions while staying aligned with global legislation, impacting pat...

Transform the regulatory landscape by shaping product communications and ensuring compliance with FDA regulations. Guide promotional reviews, mentor team members, and navigate evolving regulatory chal...

Join a dynamic team and lead regulatory strategies for in vitro diagnostics, ensuring compliance and successful submissions while collaborating cross-functionally. Manage project timelines and mentor...

Drive quality assurance for new product introductions in pharmaceuticals. Leverage leadership skills, manage cross-functional teams, and ensure regulatory compliance to deliver high-quality products e...

Shape the future of regulatory affairs by driving strategies for late-stage development programs. Collaborate across teams to ensure compliance, manage submissions, and support critical milestones in...

Lead the charge in regulatory compliance by ensuring product labeling meets global standards. Collaborate cross-functionally to navigate international regulations and enhance market access, protecting...

Join a team that's shaping regulatory strategies in biopharmaceuticals. This role involves leading regulatory submissions and collaborating across project teams to ensure compliance while advancing co...

Optimize CMC regulatory strategies for biologic products across the product lifecycle. Lead cross-functional teams to ensure compliance with global regulatory standards while driving successful submis...

Deliver impactful CMC regulatory support for IND/CTA development and maintenance, ensuring compliance and completeness across submissions while leading cross-functional collaboration and strategically...

Pioneer regulatory excellence by leading FDA submissions and compliance. Manage the lifecycle of medical product filings, ensuring alignment with evolving regulations across diverse jurisdictions in a...

Champion regulatory strategies and submissions for global medical products, ensuring compliance across major markets while leading cross-functional teams and driving process improvements in a collabor...

Lead the charge in developing and overseeing global product labeling strategies for Neuromodulation therapies, ensuring compliance with regulatory standards, and fostering cross-functional collaborati...

Elevate your career by leading global regulatory labeling strategies and initiatives. Oversee labeling governance, ensure compliance, and collaborate with cross-functional teams to support effective p...

Provide comprehensive Regulatory Affairs support to ensure full compliance with U.S. FDA medical device regulations and international standards, facilitating product submissions and ongoing industry c...

Join a dynamic team to facilitate regulatory document preparation and submission, ensuring compliance as you support U.S. regulatory activities and collaborate with cross-functional teams to execute s...

Elevate your career as you ensure regulatory compliance in product development and manufacturing. Collaborate with project teams and guide submissions to domestic and international agencies while main...

Empower global product strategy in Regulatory Affairs, leading teams to navigate complex regulations for therapeutic developments in inflammation and rare diseases. Drive global registration and lifec...

Join a team that's shaping global regulatory strategies for innovative medical devices. Leverage your expertise in Software as a Medical Device (SaMD) to make impactful submissions and ensure complian...

Engage in leading GCP audit programs, managing staff development, and implementing quality initiatives to enhance safety compliance. Contribute to a dynamic, science-focused environment dedicated to i...

Join a team that's passionate about advancing regulatory projects in the pharmaceutical industry. Drive compliance and ensure timely submissions while collaborating across functions, developing strate...

Transform U.S. regulatory strategies in Obesity and Related Conditions, ensuring compliance and patient safety. Lead teams on global initiatives and manage key submissions for clinical trials and mark...

Manage site-level regulatory operations for clinical trials, ensuring compliance with U.S. regulations. Collaborate with cross-functional teams and provide guidance for regulatory submissions, fosteri...

Transform global pharmacovigilance by leading safety assessments, managing risk, and ensuring compliance across clinical trials and regulatory submissions to enhance patient safety and product integri...