- ZOLL Medical Corporation (Chelmsford, MA)
- …assess gaps in the Quality Management System as it relates to Post Market Surveillance . + Ensure reporting requirements are compliant with ZOLL Policy ... to an effective Post Market Surveillance program. + Provide support for annual reporting... reporting , CER's, and PMA activities related to Post Market Surveillance . + Stay… more
- Philips (Cambridge, MA)
- …improvement. + You have experience/knowledge of regulations relative to Post Market Surveillance activities and reporting , such as: ISO 9001/13485/14971, ... The Director-Global Data Analytics- Post Market Surveillance will...requirements to ensure compliance in all data collection and reporting activities + Reporting to the Sr… more
- ThermoFisher Scientific (Waltham, MA)
- …countries and regions. Work closely with Quality partners to ensure Post Market Surveillance and Vigilance reporting is completed. Supports internal and ... The incumbent will also be responsible for talent development within the team. Reporting to the Senior Director of Regulatory Affairs, the incumbent will serve as… more
- Pfizer (Cambridge, MA)
- …serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety. + ... diligence reviews, and provide assistance to new business development on market opportunities and the target product profile. **ROLE RESPONSIBILITIES** **Accountable… more
- Danaher Corporation (Boston, MA)
- …510(k), de novo, technical files, pre-submissions, annual renewals, change notifications, post - market surveillance activities, etc. Provide guidance, ... + Author and/or review regulatory documents fo r global market entry , Design History Files, and perform regulatory...activities in support of CAPAs, recalls, and medical device reporting to achieve departmental and business objectives . +… more