- 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. **Qualifications** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill, and/or… more
- Cardinal Health (Boston, MA)
- …investigators participating in ongoing studies + Maintain current knowledge of FDA regulations and internal policies regarding Medical Drug Information, including ... any MSL presentations and Medical/Safety Review Committees + Provides pharmacovigilance support through collaboration with other internal stakeholders by collecting adverse event information, facilitating investigations of safety events, and identifying… more
- Medtronic (Boston, MA)
- …of similar complexity) program management and implementation Experience working with US FDA , EU Notified Bodies and/or other regulators during the review of ... technical documentation Demonstrated ability for strategic thinking, project planning and project management Experience driving initiatives and change management Strong influence management skills. Demonstrated ability to work cooperatively at all levels in an… more
- Charles River Laboratories (Boston, 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
- Sumitomo Pharma (Boston, MA)
- …and risk management regulations and guidelines, including pre- and post-marketing US FDA and/or EU ICH safety requirements** + Expertise in medical review of ... medical review of Individual case safety reports and aggregate safety reports + Knowledge of drug development in the pharmaceutical industry, including clinical research and global regulatory requirements + Experience managing safety data, expedited individual… more
- Teleflex (Chelmsford, MA)
- …processsing changes. * Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, company policies, operating procedures and ... processes. * Support internal and external audits as needed. * Back up support for the traning function. * Performs other related duties and responsibilities as assigned. * Support site goals and objectives. * Other duties as assigned. **Education / Experience… more
- Medtronic (Boston, MA)
- …cases and associated KPIs + Experience working under regulations of the FDA , notified bodies, and other regulatory agencies for successful commercial launches + ... Product launch experience working with Global teams _\#SurgicalPMO_NowHiring_ **Physical Job Requirements** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are… more
- Medtronic (Boston, MA)
- …in a manner that adheres to ethics & compliance guidelines and FDA requirements **Communication:** + Work with internal functions (marketing, customer service, ... finance, etc.) to meet targets (ie, Inventory management audits, customer service protocols, etc.) + Communicate market intelligence/competitor activity promptly, including potential sales leads, information regarding product pricing or account activity to… more
- Hologic (Marlborough, MA)
- …Deep understanding of Quality Management Systems (QMS), including ISO 13485 and FDA QMSR regulations. + Expertise in root cause analysis, CAPA, complaint ... investigations, and systemic issue resolution. + Knowledge of 5S principles for lab organization and safety. + Familiarity with new product development processes and lifecycle management for medical devices. + Advanced knowledge of electromechanical and IVD… more
- Charles River Laboratories (Boston, 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