- Organon & Co. (Plymouth Meeting, PA)
- …success with cross-geographically based cultural collaborations. + Knowledgeable about key labeling regulatory requirements worldwide, with a key strength in ... the core labeling documents (CCDS) and US labeling for marketed products; and supporting country Regulatory... labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the… more
- GRAIL (Durham, NC)
- …Planned Deviations (DARs), Complaint Handling/Post Market Surveillance, Product Labeling , and Packaging/Distribution. This individual may represent the Quality ... but not limited to all-Quality, Clinical Laboratory Operations,Technical Operations, Regulatory Affairs, Compliance, Program Management, Clinical Affairs, Supply Chain,… more
- Medtronic (Santa Rosa, CA)
- …the extraordinary. This position will be based in Santa Rosa, CA. The ** Senior Regulatory Affairs Specialist ** develops strategies for worldwide product ... training and support to other junior members of the department. + Provide regulatory review and guidance for proposed product claims/ labeling and advertising and… more
- Bausch + Lomb (Springfield, IL)
- …business outcomes. **Responsibilities:** + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical/non-clinical, labeling , adpromo ... operational excellence, compliance, and timely execution of deliverables. + Drive regulatory strategies for clinical, non-clinical, CMC and labeling development… more
- Stryker (Redmond, WA)
- We are currently seeking a ** Senior Regulatory Affairs Specialist ** to join our **Medical** **Division** to be based **Hybrid** Monday through Wednesday in ... **What you will do** As part of the Medical Regulatory Affairs team, you will work with the team... guidance throughout the product lifecycle, including development, planning, labeling , and claims, while maintaining current product registrations +… more
- Stryker (Cary, IL)
- Stryker is hiring a ** Senior ** ** Regulatory ** **Affairs** ** Specialist ** to join our Sage ... through effective communication with authorities. + Advises cross-functional teams on regulatory requirements for claims, labeling , and market access (eg,… 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 ... Plymouth, MN. In this role, you will lead the preparation and submission for regulatory approvals and identify and resolve problems. You will provide regulatory … more
- Bausch + Lomb (Madison, WI)
- …product strategy, reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence ... products in the US and/or Canada + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical/non-clinical, labeling , adpromo domains +… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …on utilizing regulatory updates to expedite approval process + Review labeling content product and process changes, and product documentation to assure ... systems. **How you'll make an impact:** + Represent the regulatory function on manufacturing and product development teams to...on contracts or projects + Ability to interact with senior internal and external personnel on significant matters often… more
- Edwards Lifesciences (Irvine, CA)
- …on utilizing regulatory updates to expedite approval process + Review labeling content product and process changes, and product documentation to assure ... difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and… more
- Edwards Lifesciences (Irvine, CA)
- …on utilizing regulatory updates to expedite approval process + Review labeling content product and process changes, and product documentation to assure ... difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …self. Become a **maker of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist , you will play a crucial role in supporting Medication ... Directive, EU Electromagnetic Compatibility Directive, etc.). + Problem-solve and escalate regulatory and compliance issues to senior management as necessary.… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Staff Regulatory Affairs Specialist , you will be responsible for supporting MMS Dispensing products consisting of Medical Devices ... regulations (eg, FDA Medical Device Regulations, EU-MDR) + Problem solve and escalate regulatory and compliance issues to senior management as necessary + Drive… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- …issues, and export and labeling requirements, with some oversight from more senior regulatory specialist / manager. + May participate with adverse ... be assigned projects to lead on their own with some guidance from senior regulatory employees/managers. + Ensures accurate population of databases for tracking… more
- Medtronic (Minneapolis, MN)
- …to innovation in a more connected, compassionate world. **A Day in the Life** ** SENIOR REGULATORY AFFAIRS SPECIALIST ** _Location: Minnesota Rice Creek East ... we provide. Therefore, we are looking for a passionate Senior Regulatory Affairs Specialist who...regulatory support for currently marketed products, including reviewing labeling and changes to existing devices and documentation. +… more
- GE HealthCare (Madison, WI)
- …GE HealthCare establishes best practices in compliance with regulatory requirements. The Senior Regulatory Affairs Specialist will be involved with ... **Job Description Summary** A trusted regulatory subject matter expert to provide guidance to...regulatory requirements flow-down, advertising and promotion review, product labeling compliance, etc. GE HealthCare is a leading global… more
- Oura (San Francisco, CA)
- …and New York) occasionally gather informally at local co-working locations. The AGC, Senior Director of Regulatory Compliance & Privacy will provide strategic ... Regulatory Compliance, this role will be responsible for advising on regulatory risk, marketing claims, product labeling , corporate compliance initiatives,… more
- Curia (Rensselaer, NY)
- Senior QA Validation Specialist - CSV Systems Engineer Summary: The Senior Validation Specialist , assists with the validation activities throughout the ... and approval, investigations for deviations and champion local, corporate and regulatory standards + Present and support validation concepts and approaches with… more
- Caterpillar, Inc. (Griffin, GA)
- …**Job summary:** The Large Power System Division currently seeking an EHS Specialist to serve as an individual contributor on the Environmental, Health and/or ... and complaints. + Ensure environmental training is completed to comply with regulatory requirements or in support of facility, division, or enterprise objectives. +… more
- Stanley Black and Decker (Elyria, OH)
- EH&S Specialist - Onsite Elyria, OH, US **Come build something that matters.** It takes great people to achieve greatness. People with a sense of purpose and ... CUB CADET(R), and HUSTLER(R). **The Job:** As an EH&S Specialist you'll be part of our Elyria, OH team...onsite for hazard communication, and to assist in chemical labeling , waste management, spill response, and annual reporting under… more
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