- 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
- Globus Medical, Inc. (Audubon, PA)
- …can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance ... Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as...a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry,… more
- Globus Medical, Inc. (Audubon, PA)
- …resume their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) ... Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as...and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes… 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
- ATS Automation (Warminster, PA)
- …& QUALIFICATIONS + Proven experience in compliance management including trade compliance regulatory affairs or similar roles + Deep understanding of ... serve as the first point of contact for trade export import and regulatory compliance inquiries working cross functionally with internal teams external partners and … more