- ThermoFisher Scientific (Pittsburgh, PA)
- …is safe or helping find cures for cancer. **Discover Impactful Work** As a Sr. Manager , Regulatory Affairs, you will play a crucial role in interpreting and ... and communicate the impact of relevant global regulations, guidelines, and evolving regulatory trends relating to pharmaceutical product development in the area… 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
- Oracle (Harrisburg, PA)
- …our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into ... for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- Oracle (Harrisburg, PA)
- …our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into ... for Clinical Evaluation Reports (CERs), including alignment with EU MDR and FDA regulatory requirements. . Oversee usability engineering (IEC 62366), ensuring… more
- Globus Medical, Inc. (Audubon, PA)
- …resume their lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance for ... for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This...21 CFR regulations. **Essential Functions** **:** + Partnering with Product Development and management to prepare and review 510(k)… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- The Senior Manager , Global Product Quality - Biologics is responsible for managing quality oversight of clinical and commercial products at CMOs under contract ... and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. This role will provide specialized… more
- Omnicell (Cranberry Township, PA)
- …or consultative role. + Proven ability to manage product development within FDA and other regulatory guidelines. **Work Conditions:** + Remote position. + ... **Summary:** The Senior Product Manager is a strategic role responsible for defining the vision, strategy, and successful delivery of OR and Procedural… more
- Globus Medical, Inc. (Audubon, PA)
- …patients can resume their lives as quickly as possible. **Position Summary** **:** The Product Manager is responsible for supporting the Biologics Product ... team, designing, developing, and managing activities for a specific product or group of products from product ...the group according to Globus quality policy and all FDA and other regulatory bodies . Obtains… more
- Kelly Services (Horsham, PA)
- …you find a job that works for you. How about this one? We're seeking a Product Manager to work at a leading, innovative biotechnology company in Horsham, PA. ... Location:** Horsham, PA **Why you should apply to be Product Manager :** + Join the Strategy &...in **pharmaceutical marketing or oncology.** + Are familiar with FDA regulatory environment, HCC regulations, and **large-scale… more
- West Pharmaceutical Services (Williamsport, PA)
- Senior Quality Manager Requisition ID: 71560 Date: Nov 26, 2025 Location: Williamsport, Pennsylvania, US Department: Quality Description: **_This is an onsite ... processes related to the manufacture of West products. Ensure compliance with regulatory requirements and West procedures. Proactively develop, lead, and drive the… more