- 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …components, randomization file and label text). + Oversee the internal packaging and labeling production orders in accordance with the clinical trial design and all ... relevant regulatory requirements for assigned projects. + Ensure the creation...teams in various areas. + Manage external packaging and labeling activities + Responsible for improving business processes and… more
- J&J Family of Companies (Danvers, MA)
- …more at https://www.jnj.com/medtech We are searching for the best talent for a ** Senior Regulatory Affairs Specialist ** to support our Abiomed business. ... and relocation assistance is not provided. **Purpose** : The Senior Regulatory Affairs Specialist is...). + Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance.… 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 (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
- 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
- Cardinal Health (Cheyenne, WY)
- …and services are properly reviewed for quality and documented. **_Job Summary_** The Senior Specialist , Quality Assurance - Labeling Team is responsible ... ** Senior Specialist , Quality Assurance - Pharmaceutical...documentation and compliance standards for pharmaceutical and medical device labeling . + Ability to interpret and apply regulatory… 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