- Lundbeck (Norristown, PA)
- …transform lives. Join us on our journey of growth! As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and… more
- Lundbeck (State College, PA)
- …grow with LundbeckOur ideal candidate will have the ability to be a specialty product expert with an understanding of requisite market complexities in order to be ... to stakeholders in the primary care and neurology settings. As an Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs, is responsible for preparing, filing and gaining ... team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and...systems and line extensions. + Assists in review of product labeling and marketing materials. + Provides regulatory… more
- Dentsply Sirona (York, PA)
- …for mentoring and providing guidance to their direct reports and cross-functional product development teams on US and EU regulatory requirements. This ... regulatory guidance and support to cross-functional teams throughout the product lifecycle. Reviews and interprets regulatory requirements and guidance… more
- CSL Behring (King Of Prussia, PA)
- …to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product /s with a patient-centric ... insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Effectively partner with assigned product /s Global … more
- 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
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …drug products and drug-device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting ... strategies for post-approval changes, line extensions, and global harmonization of product registrations. Monitor and implement regulatory updates impacting… 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
