- Medtronic (Irvine, CA)
- …of medical device experience, including knowledge of the US and International regulatory requirements for Advertising & Promotional labeling , or an advanced ... to ensure that it meets all medical, legal, and regulatory (MLR) process requirements. + Facilitate review meetings online...+ Support the preparation of US and International promotional labeling material, including the creation of a claims matrix… more
- 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
- Medtronic (Minneapolis, MN)
- …innovation in a more connected, compassionate world. **A Day in the Life** The Senior Regulatory Affairs Specialist is responsible for planning and executing ... that result from the regulatory assessment. This role is also responsible for labeling and ad prom review of assigned product family. This role partners with the… more
- Bausch + Lomb (Juneau, AK)
- …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
- 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
- Stryker (Fremont, CA)
- **Join Stryker's Neurovascular Division in Fremont, CA as a Senior Regulatory Affairs Specialist .** At Stryker, we're driven by a mission to "Make Stroke ... + Support the Neurovascular product portfolio by assessing design, manufacturing, and labeling changes to ensure regulatory compliance throughout the product… 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
- Bausch + Lomb (Juneau, AK)
- …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
- 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
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