- Danaher Corporation (Marlborough, MA)
- …behavior among employees and to prevent and detect misconduct. The Senior Compliance Manager will be the primary compliance advisor for Sciex and will be involved ... compliance program experience is preferred, but not required + Experience with FDA medical device promotional regulations. SCIEX, a Danaher operating company, offers… more
- Wolters Kluwer (Waltham, MA)
- The **Principal SaMD Technical Program Manager ** plays a pivotal role in driving the development and delivery of Software as a Medical Device (SaMD) products. This ... at high velocity while ensuring strict compliance with global regulatory standards such as FDA , EU MDR, ISO 13485, and IEC 62304. They are responsible for creating… more
- Philips (Cambridge, MA)
- …talented Hospital Patient Monitoring (HPM) Clinical Affairs team, the Senior Manager -Clinical Development is responsible for managing the day-to-day operations of ... experience in Medical Device Clinical Research and Medical Device development within FDA regulated OEM product environments. + You have proven experience in clinical… more
- Charles River Laboratories (Wilmington, MA)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your ... quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.… more
- ConvaTec (Lexington, MA)
- …Genertion, R&D External - Vendors, Clinical Sites, Regulatory approvers ( FDA , Competent Authorities, IRB/EC) **Travel Requirements** Position may involve travel ... up to 20% of the time, mostly domestic but some international travel may be required. Trips may include overnight travel. **Languages** + Speaking: Yes English + Writing/Reading: Yes English **Working Conditions** Remote Working, however, occasional travel… more
- Edwards Lifesciences (Boston, MA)
- …SoCRA clinical coordinator/ CRA certification) + Strong understanding of ISO 14155, FDA , and international regulatory requirements + Ability to lead and mentor field ... monitors + Strong understanding of risk-based monitoring, strategies and tools to ensure compliance and data integrity + Ability to resolve conflicts and provide clear guidance + Proficiency in trial management systems (eg RAVE, CTMS, Veeva, & monitoring… more
- Takeda Pharmaceuticals (Boston, MA)
- …of EU and US CMC requirements and familiarity with inspection expectations (eg, MHRA/ FDA ) and compliance practices. + Ability to travel up to 20%, domestic & ... international **Takeda Compensation and Benefits Summary** We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay… more
- Fujifilm (Boston, MA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements, and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** Experience: + 8+ years of progressive… more
- Beth Israel Lahey Health (Boston, MA)
- …a professional and timely manner, archiving records of correspondence per NIH, FDA , and/or other applicable Federal, State, and local regulations. + Develops ... program-specific performance measures to assess effectiveness and success of program components. Implements data collection processes and communicates performance through periodic reports to working and executive groups. + Has the authority to direct and… more
- Pfizer (Cambridge, MA)
- …knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA , EMA, and global regulations. + Extensive understanding of related disciplines, ... eg, Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance. + Experience working on large data sets. + Proficiency with Microsoft Office and relevant scientific software + Effective… more