- Globus Medical, Inc. (Audubon, PA)
- …patients can resume their lives as quickly as possible. **Position Summary** **:** The Manager , Regulatory Affairs , is responsible for preparing, filing and ... cleared products or systems and line extensions. + Assists in review of product labeling and marketing materials. + Provides regulatory oversight of changes in… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling ,...global regulatory team (GRL, regional leads, CMC-RA, labeling , medical writing, regulatory operations, etc.) to… more
- CSL Behring (King Of Prussia, PA)
- …of successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, ... regulatory activities/submissions and 3 years working on developmental products. Previous regulatory affairs experience is preferred. + Experience in working… more
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining clearance ... Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as...device industry or equivalent, preferably within orthopedic medical devices; Regulatory Affairs experience is a plus. +… more
- CSL Behring (King Of Prussia, PA)
- …products. **Experience** + Bachelor's Degree Life Science + Minimum 3 years in Regulatory , Medical, or Legal Affairs or other relevant experience. + Skilled ... onsite three days a week. You will report to the **Advertising & Promotional Labeling Lead, GRA Region North America** **Position Purpose** + Provide an overview of… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs , Research & Development, Legal, and Health ... and provides Medical Safety review and approval for PMS documentation, labeling /IFU creation, Clinical Evaluation Reports, developing responses to inquiries from… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs , Research & Development, Legal, and Health ... provides Medical Safety review and approval for PMS documentation, labeling /IFU creation, Clinical Evaluation Reports, developing responses to inquiries from… more