Senior Regulatory Affairs Specialist Jobs

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...

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...

Join our team to enhance regulatory compliance in clinical research, collaborating across teams and external partners to ensure successful IND and IDE submissions while driving process improvements an...

Optimize regulatory compliance for innovative diagnostics, collaborating cross-functionally to manage submissions and maintain registrations, while supporting quality systems globally and fostering pr...

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...

Seeking a detail-oriented Regulatory Affairs Specialist to manage medical device compliance, documentation, and audits, ensuring adherence to FDA and ISO standards while collaborating across teams for...

Drive regulatory strategy by guiding product development teams, ensuring compliance, and preparing documentation for global submissions. Monitor regulations and assess their impact, while fostering so...

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...

Drive excellence in board governance and regulatory filing for mutual funds. Oversee document management, provide insights on compliance, and coordinate cross-departmental efforts to ensure timely and...

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...

Transform regulatory approaches by ensuring compliance for IVD products. Engage with global teams, devise strategies for submissions, mentor peers, and navigate evolving regulations to secure market a...

Transform the future of diabetes care by guiding innovative medical devices through regulatory pathways, influencing product strategies, and ensuring compliance with global regulations while collabora...

Unlock potential by leading regulatory submissions for medical devices, ensuring compliance with FDA and international standards. Collaborate across teams to expedite approvals and maintain regulatory...

Lead the charge in regulatory compliance for diverse operations, ensuring alignment with laws and regulations. Manage corporate policies and conduct compliance audits while fostering a culture of awar...

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

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...

Shape the future of compliance by leading audits, mentoring teams, and ensuring quality adherence to regulatory standards in a dynamic environment. Drive process improvements and maintain robust quali...