- Abbott (Santa Clara, CA)
- …requested + Identify and present option for risk mitigation to decision makers + Support regulatory trackers for submissions to identify areas for new or ... regulatory environment. Demonstrates ability to interpret and apply regulatory requirements to software systems , including documentation, risk management,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Group. Responsibilities and qualifications are as follows: **Responsibilities:** + Provides support for designated regional regulatory activities for PDM CMC ... technical risk assessment exercises. + Proactively invests in own development to acquire regulatory skills and knowledge, with manager support . + Invests in… more
- BeOne Medicines (San Mateo, CA)
- … systems + Project Management Tools: Microsoft Project or Smartsheet + Regulatory Information Management (RIM) Systems (Veeva Vault, Liquent InSight, etc.) + ... **General Description:** The Senior Director of Global Regulatory Project Management is a pivotal leadership role...and retain top talent; set clear performance objectives and support career growth. + Partner with cross-functional leaders to… more
- Medtronic (Los Angeles, CA)
- …Team with business unit Regulatory Affairs Specialists (RAS) to provide regulatory support for new product introduction (NPI) and marketed products under ... negotiate submission issues with agency personnel. + Reviews protocols and reports to support regulatory submissions. + Provide support to currently marketed… more
- Medtronic (Irvine, CA)
- …with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Sustaining ... with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Sustaining … more
- Gilead Sciences, Inc. (Foster City, CA)
- …commercial activities to US regulatory agencies. You will provide commercial regulatory support for assigned brands, therapeutic area, and other projects. ... You may also attend labeling meetings. **EXAMPLE RESPONSIBILITIES:** + Provides commercial regulatory support to assigned products or therapeutic area and… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …associations, professional organizations, and standards development organizations + Ensure Regulatory resources are available to support inspections conducted ... your best self. Become a **maker of possible** with us. The Sr. Director, Regulatory Affairs is the ranking Regulatory Affairs leader for the Dispensing RA… more
- Envista Holdings Corporation (Brea, CA)
- …maintain procedures, standard operating procedures (SOPs), and technical documentation to support regulatory operations and ensure clear, compliant, and ... issued by relevant authorities, assess their impact on the organization, and provide timely regulatory guidance and support to ensure compliance. + Develop and… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed ... and regulatory obligations. **J** **ob Responsibilities** - Provides critical support in developing global regulatory strategy, planning and execution of… more
- Abbott (Alameda, CA)
- …international medical device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices including Quality Systems ... the spectrum of customer needs. Projects will focus on driving the regulatory strategy for business partnership initiatives involving Cloud/ Sensor based external… more