- GE HealthCare (Waukesha, WI)
- **Job Description Summary** This position provides regulatory strategy and direction of SaMD to the Magnetic Resonance business regarding healthcare industry ... regulatory requirements for integration, product launch, premarket submissions/registrations and...functional developments in own area. Contributes towards strategy and policy development and ensures delivery within area of responsibility.… more
- ThermoFisher Scientific (Wilmington, NC)
- … strategy alignment. **Key Responsibilities** + **Monitor & Analyze:** Track global regulatory changes, guidance documents, and policy trends across key markets ... intelligence within the biopharmaceutical industry. + Strong understanding of global regulatory frameworks and drug development lifecycle. + Excellent… more
- Stryker (Tempe, AZ)
- …issues throughout the product lifecycle + Leads the development and execution of good regulatory practices and policy + Provides strategic input on regulatory ... The **Director, Regulatory Affairs** is a key strategist, responsible for...of 3 days. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance,… more
- Takeda Pharmaceuticals (Boston, MA)
- …experience + Preferred experience in reviewing, authoring, or managing components of regulatory submissions. + Solid working knowledge of drug development ... + Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple… more
- Chiesi (Boston, MA)
- …for the better. Who we are looking for Purpose Responsible for the regulatory review and submission of advertising and promotional materials for multiple Chiesi ... and changes to existing labeling, and submission of labeling information to regulatory authorities in the United States and Canada. Main Responsibilities +… more
- Houston Methodist (Houston, TX)
- At Houston Methodist, the Regulatory Compliance Specialist position is responsible for coordinating and performing study specific regulatory processes such as ... (GCP) and all local, state, and federal laws, regulations, guidance, policy and procedure developed by Houston Methodist Research Institute Institutional Review… more
- Takeda Pharmaceuticals (Boston, MA)
- …inclusive of regulatory and/or related experience. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA is a ... and make a lasting impact on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the global regulatory team.… more
- Takeda Pharmaceuticals (Boston, MA)
- …of regulatory and/or related experience. + Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ... make a lasting impact on patients worldwide. Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will be part of the global regulatory … more
- Pentax Medical (Montvale, NJ)
- …devices and solutions to the global medical community. Position Opening: Senior Regulatory Affairs Specialist Why JOIN Us? We are an established medical device ... proud of its comprehensive benefits program and generous Paid Time Off and Holiday policy . Want More INFO? In this role, the specialist will work under the guidance… more
- BeOne Medicines (Emeryville, CA)
- …process, the pharmaceutical industry and healthcare environment including Global and EU/UK regulatory requirements and policy trends + Recent experience with ... **General** **Description:** The Director, Regulatory Affairs, Dx/CDx and Medical Devices will be...for leading a small team for developing and implementing regulatory diagnostic and medical device strategies as applicable, for… more