- Actalent (South San Francisco, CA)
- …Advertising, Promotion & Labeling (Part Time) Job Description The Regulatory Labeling Manager serves as a vital member of the MLR team, providing strategic, ... Independently review and approve promotional materials to ensure compliance with FDA regulations, product labeling, guidance documents, and internal policies. +… more
- Boehringer Ingelheim (Ridgefield, CT)
- …for NCEs/NBEs and labeling supplements, in conjunction with the assigned RA Labeling Content Manager and Product Manager in the RA Product Groups. The AD, DRA ... support labeling initiatives in compliance with Corporate and local regulatory requirements . The AD, DRA Product Labeling Operations will provide training, advice,… more
- MPE Inc. (Sturtevant, WI)
- …variation. + Manages complaints, CAPA, non-conforming products per applicable ISO13485 and FDA requirements . + Manage inputs and KPI metrics for management ... Quality Manager $95K to $120K At MPE we are dedicated...review process per ISO13485 and FDA requirements . + Maintain Medical Device Files and records per ISO… more
- Hologic (Marlborough, MA)
- …communications, and health risk assessments. + Proven track record in implementing FDA and international regulatory requirements for recalls and market ... Manager , Field Actions Newark, DE, United States Marlborough,...execution of global field actions, ensuring compliance with regulatory requirements and maintaining the highest standards of quality and… more
- Biomat USA, Inc. (Chicago, IL)
- …and services in more than 110 countries and regions. Acknowledgment: The Operations Manager is a key member of the donor center leadership team, responsible for ... activities align with company standards, SOPs, and applicable regulatory requirements . Summary: Assists with operational management of a Plasma...of the center. Acts on behalf of the Center Manager in his/her absence, may manage the center alone… more
- Actalent (Broomfield, CO)
- Job Title: Scientific Program Manager Job Description We are seeking a Scientific Program Manager to drive the execution of complex in vitro diagnostics (IVD) ... and delivering large volumes of analytical and clinical testing required for FDA and IVDR submissions. The successful candidate will bring strong scientific… more
- Biomat USA, Inc. (Raleigh, NC)
- …and services in more than 110 countries and regions. **Acknowledgment** : The Operations Manager is a key member of the donor center leadership team, responsible for ... activities align with company standards, SOPs, and applicable regulatory requirements . **Summary** : Assists with operational management of a...of the center. Acts on behalf of the Center Manager in his/her absence, may manage the center alone… more
- Boehringer Ingelheim (Ridgefield, CT)
- …performance based bonus, relocation and or other compensation elements. **Description** The Manager , HP Review Committee is a strategic partner and the single point ... will need early alignment, review, approval, production and submission to the FDA at time of 1st use (if appropriate). Ensures appropriate TA/brand prioritization… more
- Bristol Myers Squibb (Summit, NJ)
- … QC Microbiology is responsible to act as the SME during regulatory inspections. ** Requirements ** + Advanced knowledge of cGMP's, FDA , USP, MHRA, BP, EP, JP, ... at BMS with our Cell Therapy team. The Sr. Manager , QC Microbiology, is a highly critical role and...microbiological identification. Sampling and testing must meet or exceed FDA , MHRA, PMDA, EU, and other governmental regulations or… more
- Biomat USA, Inc. (Kansas City, MO)
- …solutions and services in more than 110 countries and regions. **Job Title:** CENTER MANAGER **Summary:** Acts as the general manager for a Plasma Collection ... assigned team, other center staff and other centers. + Through Assistant Manager , oversees donor selection, plasma collection and shipment and records completion. +… more