- Chemours (Harrisburg, PA)
- …Engineering, Biological Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect ... outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer… more
- Globus Medical, Inc. (Audubon, PA)
- …improvement, or manufacturing operations. + Strong understanding of medical device manufacturing, regulatory compliance , and quality assurance ... accuracy and resolving outstanding lot inspections. + Work with Regulatory teams (US and international) to ensure compliance...and fast-paced team dedicated to innovation and efficiency in medical device development. + Make a meaningful… more
- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... years (with Bachelor) or 2+ years (with Masters/PhD) of medical device regulatory experience +...detail with planning, time management and organizational skills + Regulatory compliance competency including Quality Systems +… more
- Wolters Kluwer (Philadelphia, PA)
- …the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry eg, ISO, QSR, GMP. Must have EU MDR and FDA ... on-market medical devices including Software as a Medical Device (SaMD) within the Health Division...subject matter expert. + Assure integration and support of device regulations and compliance with company policies… more
- Fujifilm (Harrisburg, PA)
- …to Division General Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with ... part of the legal team providing support to the Medical Device businesses of FUJIFILM Healthcare Americas...respect to healthcare regulatory compliance , anti-kickback statutes, the False Claims Act, US government… more
- Jabil (West Chester, PA)
- …meetings (eg, CAC, TIC, MIC, QIC). + Engage in internal/external audits and regulatory compliance activities. + Provide training and guidance to manufacturing ... Quality Engineer, you will support key quality systems, ensure compliance with internal and regulatory standards, and...Quality Engineering (eg, CQE) is a plus. Benefits + Medical , Dental, Prescription Drug, and Vision Insurance with HRA… more
- Jabil (West Chester, PA)
- …and foster vibrant and diverse communities around the globe. Are you experienced in Regulatory Compliance ? Jabil is seeking a qualified Regulatory ... Manager to work in West Chester, PA. As the Regulatory Compliance Manager, you will manage all...least five (5) years of experience in the QSR/ISO-regulated medical device operation, including 2-3 years specific… more
- System One (Malvern, PA)
- …or equivalent, in life sciences related field. + RAC certification. + 15+ years Regulatory Affairs in medical device field with management responsibilities. ... Hire Essential Duties/Responsibilities: + Manage Regulatory and Medical Affairs SOPs to ensure full compliance ...Manage and maintain ongoing submissions such as annual reports, medical device facility registrations and device… more
- Globus Medical, Inc. (Audubon, PA)
- …or equivalent; Engineering degree is a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, , preferably within ... and PMA reporting + Reviews Document Change Orders for Regulatory compliance , including drawings and labeling changes...orthopedic medical devices; + Experience in medical device development and registration of products… more
- Globus Medical, Inc. (Audubon, PA)
- …work experience + 5+ years of related experience in the medical device industry + Understanding of regulatory requirements throughout the product lifecycle + ... At Globus Medical , we move with a sense of urgency...changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance . Monitors and improves tracking and… more