Senior Regulatory Affairs Specialist Jobs

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...

Lead and manage the supplier quality program to ensure compliance with regulatory standards, execute supplier evaluations, and support audits for a seamless quality management system in a dynamic envi...

Accelerate product success by leading regulatory initiatives from development to commercialization, ensuring compliance with FDA and international standards, while mentoring teams and making strategic...

Empower your career by developing regulatory strategies to ensure timely market access for innovative medical devices. Collaborate with cross-functional teams to guide product development and mitigate...

Lead the charge in developing and implementing effective regulatory strategies for new and sustaining products in alignment with company goals, ensuring compliance and facilitating device approvals in...

Drive regulatory compliance by developing submissions and strategies for medical devices. Collaborate across teams to ensure timely approvals while adhering to global standards and practices in a dyna...

Lead global regulatory strategies in oncology, ensuring timely approvals and innovative approaches. Collaborate with cross-functional teams, manage risks, and influence stakeholders to deliver life-ch...

Champion the global regulatory strategy for complex CGT products, driving approval pathways and guiding cross-functional teams. Leverage your expertise in oncology and cell therapy to influence stakeh...

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...

Drive regulatory project execution for medical devices and combination products, ensuring compliance with global standards while collaborating with cross-functional teams to manage timely submissions...

Join a dynamic team as you drive regulatory strategies and submissions for critical healthcare devices while collaborating across functions to ensure compliance and product excellence throughout the l...

Support cross-functional teams by providing regulatory guidance for IVD product development, developing strategies, and conducting risk assessments to ensure compliance with FDA and EU regulations for...

Contribute to regulatory compliance by managing 510(k) submissions and ensuring that products meet FDA and Canadian regulations. Collaborate across teams to maintain clear processes and uphold product...

Elevate global regulatory strategies for a diverse medical device portfolio, ensuring compliance and market access across regions. Lead cross-functional teams while influencing product lifecycle and e...

Partner with us to ensure seamless FTZ operations and compliance for cell therapy logistics. You'll manage inventory integrity and align cross-functional teams to support critical patient material shi...

Join a dynamic team as a Regulatory Affairs Specialist III, ensuring compliance with global regulations. Contribute strategically to product development and lifecycle management while collaborating ac...

Drive regulatory compliance for cutting-edge surgical medical devices, enhancing product access globally. Collaborate cross-functionally and provide guidance on regulatory strategies, ensuring alignme...

Join us to ensure regulatory compliance and drive excellence in our Surgical portfolio. You'll support regulatory strategy execution for medical devices, collaborate cross-functionally, and facilitate...

Shape the future of quality control operations by leading technical initiatives, managing compliance, and driving continuous improvement in laboratory practices while collaborating with cross-function...

Engage as a technical leader in QC Operations to enhance quality systems and drive continuous improvements. Collaborate across departments, lead critical initiatives, and ensure compliance in a regula...

Lead the charge in regulatory submissions for EU and ex-U.S. markets, managing CTA preparation and execution, while collaborating across teams to ensure compliance and timely approvals in a fast-paced...

Join a team dedicated to transformative regulatory compliance, focusing on EU and ex-U.S. clinical trial applications. Lead critical submission strategies and foster collaboration across functions to...

Unlock the potential of real-world data by guiding clinical research efforts. Collaborate cross-functionally to execute impactful studies and drive long-term strategies in Urology, enhancing the evide...

Join our dynamic Urology team as a Senior Clinical Research Specialist, guiding real-world evidence strategies to enhance clinical research activities, improve patient outcomes, and support innovative...

Unlock potential by driving continuous improvement of our global GxP Document Management Program. Oversee document control processes, ensuring compliance with industry standards while collaborating ac...