- Merck & Co. (Rahway, NJ)
- …portfolio of clinical trials.- GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The ... clinical supplies. Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply… 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
- Medtronic (Santa Rosa, CA)
- …This position will be based in Santa Rosa, CA or Mounds View, MN. The ** Senior Regulatory Affairs Specialist ** will support Research and Development programs ... to support the operating units' (OU's) innovative pipeline. The specialist will work in collaboration with Regulatory ...to other junior members of the department. + Provide regulatory review and guidance for proposed product claims/ labeling… more
- Abbott (Sylmar, CA)
- …fingersticks. **The Opportunity** Our location in Sylmar, CA currently has an opportunity for a Senior Regulatory Affairs Specialist -China. As a Senior ... knowledge on regulatory matters. What You'll Work On * As the Senior Specialist in Regulatory Affairs Sub-Function, considered as highly experienced… 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
- Kelly Services (Cary, IL)
- ** Senior Regulatory Affairs Specialist ** + **Type:** W2 contract (NO C2C OR THIRD PARTY) + **Location:** Cary, Illinois (60013) -100% onsite + **Length** : ... authorities on regulatory paths and clinical plans + Provides regulatory guidance on strategy for proposed product claims/ labeling + Ensures clinical… 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
- 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 online and offline...+ Support the preparation of US and International promotional labeling material, including the creation of a claims matrix… 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) (Milpitas, CA)
- **Job Description Summary** BD Life Sciences is recruiting for a Senior Regulatory Affairs Specialist in San Milpitas, CA. The Sr. Regulatory Affairs ... a **maker of possible** with us. **Position Summary:** The Senior Regulatory Affairs Specialist will...regulations and guidelines. + Review and approve product labels, labeling , and promotional materials for regulatory compliance.… 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
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- **Job Description Summary** We are seeking a Senior International Regulatory Affairs Specialist to join our Regulatory Affairs team. This role is ... us. **Position Summary:** We are seeking a Sr. International Regulatory Affairs Specialist to join our ...collection for submissions. + Review and approve product labels, labeling , and promotional materials for regulatory compliance.… more
- Newell Brands (Wichita, KS)
- …and hydration/thermal drinkware. We are seeking a Senior Product Safety Specialist to lead product safety and regulatory compliance activities for assigned ... categories; act as the subject-matter expert guiding cross-functional teams through regulatory pathways and retailer requirements, ensure that all certification and … 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
- Merck (West Point, PA)
- …of this position revolve around the detailed workings of clinical packaging, labeling and distribution activities and associated regulatory submissions for ... of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent… more
- Cardinal Health (Phoenix, AZ)
- …procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant ... release, facilities and equipment, material controls, laboratory controls, packaging and labeling , and production & process controls. + Establishes and reports… more
- Kelly Services (Winston Salem, NC)
- **Job Title:** QA Specialist II - Contract **Location:** Winston Salem, NC **Schedule:** Monday-Friday, 8:00 AM - 5:00 PM **Employment Type:** Contract **Pay Rate:** ... $30-$33/hour **Position Summary:** The QA Specialist II provides critical Quality Assurance (QA) support to Quality Operations, with a strong emphasis on material… more
- ThermoFisher Scientific (Bohemia, NY)
- …building a fulfilling career with us. **Location/Division Specific Information:** Clinical Labeling Services, part of the Clinical Trials Division, located in ... in-house variable and non-variable print capabilities, and proprietary translation and regulatory approval system are designed to reduce overall clinical trial label… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Life at Olympus (https://www.olympusamerica.com/careers) . **Job Description** As a Medical Safety Specialist II (MSSII) you will have an integral role in the ... Olympus therapeutic areas. You will report directly to the Senior Director Medical Safety as a member of the...well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs, Research & Development, Legal, and Health Care… more
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