Regulatory Affairs Specialist Jobs in Boulder, CO

Join a team that's shaping the future of active implantable medical devices by supporting clinical evaluations and regulatory submissions. Collaborate across disciplines to ensure compliance with EU a...

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...

Execute R&D and Regulatory IT projects, ensuring compliance and timely delivery while leading cross-functional teams and managing system enhancements for optimal performance within budget constraints...

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

Lead the charge in developing and implementing compliance processes within Engineering and Operations. Ensure adherence to laws and regulations while enhancing operational efficiency through collabora...

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...

Join a team that's driving global regulatory compliance and product stewardship initiatives, ensuring alignment with commercial strategies and effective management of risks to support business growth...

Champion quality assurance excellence in GMP for drug substance and products, overseeing compliance and methodologies. Collaborate to ensure regulatory adherence while maintaining operational efficien...

Drive global quality compliance initiatives by leading audits and ensuring regulatory adherence across various facilities and stakeholders. Champion compliance risk identification and resolution while...

Champion regulatory excellence by leading compliance initiatives and submission strategies for in vitro diagnostics, ensuring adherence to U.S. and European regulations while partnering with cross-fun...

Join us to ensure compliance with FDA, EU, and ICH requirements, while performing quality evaluations and supporting cross-functional teams to enhance quality assurance processes and maintain a cultur...

Join a team that's dedicated to excellence in Quality Control activities, ensuring compliance and accuracy in complex research submissions. Collaborate with leadership to enhance workflow and drive co...

Drive quality assurance by collaborating with suppliers to ensure optimal parts and materials, supporting new product development efforts, and fostering continuous improvement to meet healthcare indus...

Help us drive sales growth as you support diverse industries with our Reference Materials and Analytical Standards. Leverage your expertise to build relationships, meet targets, and enhance customer e...

Optimize validation processes by independently planning, executing, and documenting activities in a sterile manufacturing environment. Ensure compliance with cGMP, FDA, and EU regulations to enhance p...

Deliver quality assurance leadership by managing product lifecycle processes, ensuring compliance, and effectively collaborating across teams to enhance product integrity and customer satisfaction in...

Pioneer clinical excellence by supporting multiple studies, ensuring compliance with regulations, timelines, and SOPs. Collaborate cross-functionally to generate high-quality clinical evidence while m...

Join a team that's committed to excellence in clinical research management overseeing trials and ensuring compliance. Lead a dedicated group, ensure protocol integrity, and communicate effectively wit...

Elevate clinical research standards by managing trials, ensuring compliance, and leading a dedicated team to deliver results in health tech. Collaborate with sponsors and adapt protocols for successfu...

Champion compliance initiatives by conducting research, analyzing trends, and collaborating with teams to ensure accurate and effective regulatory responses. Leverage data-driven insights to support c...

Transform the clinical trial landscape by leading site monitoring efforts, ensuring compliance and quality in study execution, while collaborating with diverse teams to enhance recruitment, training...

Drive quality assurance processes ensuring compliance with GMP and cGMP standards. Collaborate with external partners on activities such as batch record review, product release, and quality metrics wh...

Advance your career in regulatory advertising by leading compliance initiatives for promotional materials. Provide strategic guidance across teams, ensuring effective communications that satisfy FDA r...

Manage key regulatory functions, guiding compliance in PBM, pharmacy, and healthcare technology. Advise on state and federal obligations, and translate regulations into practical strategies for busine...

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...