- Globus Medical, Inc. (Audubon, PA)
- …and ability to respond and adapt to changing priorities + Perform duties in compliance with applicable FDA and state regulations as well as standards including, ... but not limited to, ISO 13485 and ISO 11607 **Education and Experience** + Bachelor's degree with 3 years of experience + Bachelor's degree in Mechanical Engineering, Packaging Engineering or any related technical discipline + Previous medical device packaging… more
- Community Health Systems (Dunmore, PA)
- …positioning, imaging techniques, and radiation protection. + Strong understanding of FDA /MQSA, ACR, and state regulatory compliance requirements. + Ability ... of breast diseases. This role requires advanced technical skills, adherence to FDA /MQSA, ACR, and state regulatory standards, and a strong commitment to patient… more
- J&J Family of Companies (Horsham, PA)
- …health for humanity. Learn more at https://www.jnj.com **Job Function:** Legal & Compliance **Job Sub** **Function:** Health Care Compliance **Job Category:** ... the best talent for a **Senior Manager, Health Care Compliance Officer** to be based in Horsham, PA. Our... programs and policies, Federal health care programs, and FDA requirements required. + Consistent track record of working… more
- Jabil (West Chester, PA)
- …vibrant and diverse communities around the globe. Are you experienced in Regulatory Compliance ? Jabil is seeking a qualified Regulatory Compliance Manager to ... work in West Chester, PA. As the Regulatory Compliance Manager, you will manage all Regulatory Compliance...audits: eg Notified Body, Ministry of Health country inspections, FDA , J&J Corporate Audits for site. + Audit preparation… more
- Charles River Laboratories (Wayne, PA)
- …River operations and serves as a member of the Regulatory Affairs and Compliance management team. Provides direction in implementing the Charles River Compliance ... improve the program. **Essential Duties** ⦁ Communicate all identified compliance and quality risks to his/her supervisor. ⦁ Develop...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- United Therapeutics (Harrisburg, PA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... about pharmacovigilance! You are a team player who loves quality, compliance , finding solutions and ensuring training standards are implemented and successful.… more
- Globus Medical, Inc. (Audubon, PA)
- …submissions, and approval for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This position entails development of ... FDA submissions, requires working knowledge of products under review...PMA reporting + Reviews Document Change Orders for Regulatory compliance , including drawings and labeling changes + Performs routine… more
- Globus Medical, Inc. (Audubon, PA)
- …submissions, and approval for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This position entails development of ... FDA submissions, requires working knowledge of products under review...PMA reporting + Reviews Document Change Orders for Regulatory compliance , including drawings and labeling changes + Performs routine… more
- Globus Medical, Inc. (Audubon, PA)
- …submissions, and approval for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This position entails development of ... FDA submissions, requiring working knowledge of products under review...PMA reporting + Reviewing Document Change Orders for Regulatory compliance , including drawings and labeling changes + Performing routine… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …and performs all functions associated with packaging of clinical trial supplies and assures compliance to GMPs, SOPs, FDA , DEA and OSHA rules and regulations in ... is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, and Catalent employee.** **The… more