- Cardinal Health (Annapolis, MD)
- **_What Regulatory Affairs and Clinical Submissions contributes to Cardinal Health_** The _Manager, Regulatory Affairs ( Clinical Submissions)_ is ... or timelines. + **Leadership & Team Development** + Lead, mentor, and develop junior regulatory affairs staff, providing training and guidance on regulatory … more
- United Therapeutics (Silver Spring, MD)
- …and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Senior Regulatory Affairs Manager partners with senior regulatory ... regulatory submissions and department activities. This role serves as a Regulatory Affairs representative on project teams, interpreting issues and advising… more
- Kennedy Krieger Institute (Baltimore, MD)
- **Overview** The Project Manager (Accreditation and Regulatory Affairs ) will support accreditation and regulatory functions of Kennedy Krieger Institute ... to ensure continuous compliance with federal, state, and local regulatory requirements including but not limited to, The Joint Commission (TJC), Centers for Medicare… more
- Johns Hopkins University (Baltimore, MD)
- …JHU equivalency formula. **Preferred Qualifications** + PhD + Extensive experience with clinical research sciences, regulatory affairs . + Extensive ... _Responsible for the recruitment, education, training and supervision of the clinical research coordinators and regulatory personnel within the Program._… more
- Johns Hopkins University (Lutherville, MD)
- …Medicare and Medicaid Services, and Environmental of Care. + Work with the JHH Regulatory Affairs Office, JHHS Compliance Office, JHU CPA, and Office of Billing ... The Department of Otolaryngology is seeking a **_CO_** **_Clinical Nurse Manager_** the Clinical Nurse Manager collaborates with the Medical Director and Clinic… more
- TestPros (Silver Spring, MD)
- …and regulatory requirements. + Collaborate with cross-functional teams, including Regulatory Affairs , Product Development, and Project Management, to ensure ... Summary: We are seeking an experienced Quality Assurance (QA) Manager to lead our QA efforts in responding to...compliance issues. Qualifications: + Bachelor's degree in Quality Assurance, Regulatory Affairs , Life Sciences, or a related… more
- Sumitomo Pharma (Annapolis, MD)
- …of expiry dates and communicates changes to contract manufacturing organizations, testing laboratories, clinical sites and regulatory affairs as needed. + ... and suppliers of drug substances and drug products used for investigational clinical trials and/or commercial phases. The Senior Manager ensures compliance… more
- Edwards Lifesciences (Annapolis, MD)
- …our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for ... clinical trials with skill levels exceeding the requirements of the Associate Manager Required + Experience in clinical trial design, indication lead +… more
- Fujifilm (Annapolis, MD)
- …+ Proven track record working with Marketing, Business Development, Engineering/QA, and Regulatory Affairs . + Competitive knowledge of Medical IT and Imaging ... US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all...at least 1-2 years direct experience as a Product Manager within HCUS/MIPD + Strong understanding of clinical… more
- Catalent Pharma Solutions (Harmans, MD)
- …plans. This position reports directly to the Senior Vice President of Quality & Regulatory Affairs and will have strong working relationships with VP General ... accountable for ensuring the successful delivery of quality and regulatory strategy and operational performance for the Maryland campus....Manager Maryland and other Site Leadership team members. Working… more
- Koniag Government Services (Silver Spring, MD)
- …+ Certifications or specialized training in areas such as medical writing, regulatory affairs , or scientific communication + Strong presentation and public ... via email only and have not been interviewed by the KGS hiring manager , feel free to contact_ _KGSrecruiting@koniag-gs.com_ _to verify its validity._ **Koniag IT… more
- CSL Plasma (Halethorpe, MD)
- …Staff Associates for completion of training and recommendation for certification by Regulatory Affairs . Functionally directs the Center Medical Staff. Provides ... appropriate physician the duties of "laboratory director", "technical consultant", or " clinical consultant" as prescribed by the Clinical Laboratory Improvement… more