- Novo Nordisk (Plainsboro, NJ)
- …This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues. Relationships Reports ... The Labeling Specialist supports the development of labeling activities for all regulatory submissions. This individual collaborates cross-functionally… more
- Integra LifeSciences (Princeton, NJ)
- …pathways to advance patient outcomes and set new standards of care. The Sr. Regulatory Affairs Specialist is a seasoned senior professional role responsible ... in the US, EU, Canada and globally. The Sr. Regulatory Affairs Specialist is responsible...establishing labeling requirements per regulations and review labeling that requires regulatory review and approval… more
- Cardinal Health (Trenton, NJ)
- Cardinal Health is seeking a Principal Regulatory Affairs Specialist to support the Medical Solutions Regulatory Affairs team. The selected candidate ... mentor to less experienced colleagues **_Responsibilities_** + The Principal Regulatory Affairs Specialist is responsible...with design inputs and design outputs + Review product labeling for compliance with global labeling regulations… more
- Globus Medical, Inc. (Audubon, PA)
- …in submissions, license renewal and annual registrations. Recommends changes for labeling , manufacturing, marketing and clinical protocol for regulatory ... possible. **Position Summary** **:** Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with… more
- Globus Medical, Inc. (Audubon, PA)
- …so patients can resume their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist drafts, submits and gains clearance for ... and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes...a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry,… more
- ThermoFisher Scientific (Bridgewater, NJ)
- …Education A Bachelor's degree or equivalent experience in Environmental Science, Chemistry, Regulatory Affairs , Industrial Safety, or a related field is ... regulations and appropriate qualifications. + Certification in hazardous materials handling or regulatory affairs is a plus. **Knowledge, Skills, Abilities** +… more
- CSL Behring (King Of Prussia, PA)
- …The Specialist collaborates with internal teams to align training and labeling materials with medical standards, represents Medical Affairs at conferences, ... **Summary:** The Medical Information Specialist is responsible for providing accurate, balanced, and...and mentor new Medical Information Specialists, fellows, and Medical Affairs staff. + Contribute to labeling updates… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …at least four years of experience + Strongly preferred degree in Regulatory Affairs , Biotechnology, Manufacturing, Operations, Supply Chain, Engineering or ... **Senior Quality Assurance Supplier Specialist ** **Position Summary:** Catalent, Inc. is a leading...Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be… more
- CSL Behring (King Of Prussia, PA)
- …MA team. + Partner with and share expertise with the _global_ functions of Medical Affairs , ABC, CRD, R&D, Regulatory affairs , Global Clinical Safety & ... Director, will lead the development and execution of Medical Affairs strategies and tactics in support of the US...clinical expert in the assigned TA(s). Provide input on labeling and regulatory strategy. Maintain in-depth understanding… more
- J&J Family of Companies (Spring House, PA)
- …Global Medical Safety, Delivery Unit and Trial Management, Portfolio Asset management, and Regulatory Affairs . As as ummer i ntern in a Cross-Functional A ... study design and protocols for clinical trials that support regulatory submissions and product labeling + Engage...in data management to enable system level software designs Regulatory Affairs Associate: + Conducting a research… more