- Cardinal Health (Salt Lake City, UT)
- **What Regulatory Submissions Operations contributes to Cardinal Health** Regulatory provides regulatory affairs and product development consulting ... subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting. … more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …products. + Prepare responses to regulatory agency inquiries. + Compile regulatory submissions through coordination with other departments and research of ... a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for...a very timely and accurate manner. **_Sr Reg Affairs Specialist I_** **Primary responsibilities for role:** + Act as… more
- Actalent (Agoura Hills, CA)
- Job Title: Regulatory Specialist Job Description As a Senior Regulatory Specialist , you will develop and implement medical device regulatory ... worldwide regulatory bodies. This role involves developing and authoring regulatory submissions , providing critical input on cross-functional project teams,… more
- Integra LifeSciences (Braintree, MA)
- …and making headway to help improve outcomes. The Sr. Regulatory Affairs Specialist is a seasoned senior professional role responsible for contributing to and ... in the US, EU, Canada and globally. The Sr. Regulatory Affairs Specialist is responsible for providing...strategies, and revise technical documentation for existing and new regulatory submissions . + Lead in the development… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance ... for 510(k) submissions , and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for...and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs… more
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist , Regulatory Affairs...of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, ... including Premarket Notifications and Technical Documentation for CE Marking. The Senior Specialist ensures timely and high-quality execution of all… more
- Abbott (Abbott Park, IL)
- …Opportunity** Our location in Lake Bluff, IL, currently has an opportunity for a ** Senior Specialist - Regulatory Affairs** . As an individual contributor, ... the function of a Senior Regulatory Affairs Specialist is...assay support. + Compile, prepare, review and submit on-market regulatory submissions to authorities. + Work with… more
- Abbott (Santa Clara, CA)
- …catheters, imaging catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite ... Division. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is...for submission filing. + Compile, prepare, review and submit regulatory submissions to authorities. + Monitor impact… more
- Abbott (Alameda, CA)
- …best place to work for diversity, working mothers, female executives, and scientists This ** Senior Regulatory Affairs Specialist ** will work on-site out of ... with our new sensing technology. **The Opportunity** As an individual contributor, the Senior Regulatory Affairs Specialist will support product development… more
- Abbott (Plymouth, MN)
- …get on with their lives. **The Opportunity** Abbott is seeking a passionate, experienced ** Senior Regulatory Affairs Specialist ** to join our team on-site in ... affiliates. + Compile, prepare, review and submit medical device submissions to regulatory agencies + Interfaces directly with FDA and other regulatory… more