- Community Health Systems (Dunmore, PA)
- …treatment of breast diseases. This role requires advanced technical skills, adherence to FDA /MQSA, ACR, and state regulatory standards, and a strong commitment ... positioning, imaging techniques, and radiation protection. + Strong understanding of FDA /MQSA, ACR, and state regulatory compliance requirements. + Ability… more
- Oracle (Harrisburg, PA)
- **Job Description** This role is dedicated to understanding healthcare regulatory requirements (such as HIPAA, HITRUST, FDA , etc.) and guiding cross-functional ... functions. Excellent communication, documentation, and executive presentation skills. Familiarity with regulatory frameworks (eg, HIPAA, HITRUST, FDA ) and their… more
- Teva Pharmaceuticals (West Chester, PA)
- Director, Regulatory Affairs Date: Dec 2, 2025 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: 65113 **Who we are** ... new people to make a difference with. **The opportunity** The Director, Global Regulatory Affairs, is a strategic role that will be responsible for developing,… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory intelligence. + Previous interactions with FDA or other health authority ... The Associate Director of Regulatory Intelligence leads the collection and dissemination of...and device development process, laws, regulations, and guidelines from FDA , EMA, PMDA, ICH, etc. + General knowledge of… more
- CSL Behring (King Of Prussia, PA)
- …therapies that make a meaningful difference worldwide. **Position Description Summary:** Regulatory leaders who leverage regional regulatory experience to ... actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product/s with a patient-centric focus,… more
- Bausch + Lomb (Harrisburg, PA)
- …solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies. + Monitors FDA and FTC ... abreast of market promotional and advertising strategies. + Provide regulatory support as needed for FDA warning...+ Provide regulatory support as needed for FDA warning and untitled letters, FTC letters, and direct… more
- J&J Family of Companies (Horsham, PA)
- … submissions and interactions with Health Authorities (and particularly the US FDA ) and helps to ensure regulatory post-marketing commitments are efficiently ... and evidence generation efforts, ensuring alignment with business objectives and regulatory standards. This position resides in the Medical Affairs Gastroenterology… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …or medical device industry. **Knowledge, Skills, Abilities** + Strong knowledge of regulatory requirements (eg, FDA , EMA, ISO standards). + Effective ... and suppliers. This role ensures that all quality standards and regulatory requirements are met, fostering strong relationships and maintaining compliance across… more
- Teleflex (Wyomissing, PA)
- …control processes, agile systems, and creation of design documentation. * Solid knowledge of regulatory and quality standards ( FDA 21 CFR Part 820, ISO 13485, ... members, and leads projects aligned with strategic objectives and regulatory requirements. Acting as a subject matter expert, this...preparation activities in support of quality system requirements (eg, FDA 21 CFR Part 820, ISO 13485, ISO 17025).… more