- Fresenius Medical Center (Waltham, MA)
- …RESPONSIBILITIES: + A seasoned, experienced professional with a full understanding of complaint handling/ post market surveillance , resolves a wide range of ... methods and techniques for obtaining solutions. + Networks with senior internal and external personnel in own area of...knowledge of drug/device regulatory requirements in order to support Post Market Clinical Surveillance MDR/ADE… more
- Hologic (Marlborough, MA)
- Sr . Manager Post Market Quality...and EU Medical Device Regulation (MDR). + Expertise in post - market surveillance activities such as complaint ... and ensuring customer satisfaction in a regulated industry? We're seeking a ** Senior Manager, Post - Market Quality** to lead critical post - market … more
- Hologic (Marlborough, MA)
- …the necessary skills and experience to assess potential global field actions, complaints, Post Market Surveillance activities and nonconforming events to ... QMS + Vigilance and MDR reporting, as needed + Post Market Surveillance + Nonconforming...internal stakeholders. + Consults with and provides advice to senior management on strategies and plans for regulatory product… more
- Fresenius Medical Center (Lawrence, MA)
- …ensure compliant products, engineering teams are supported with a value-added mindset, and Post Market Surveillance activities are performed, and actions ... implementation of appropriate cybersecurity measures . Evaluation of events ( post - market surveillance ) within the scope...methods and techniques for obtaining solutions. . Networks with senior internal and external personnel in own area of… more
- Hologic (Marlborough, MA)
- …manage NCEs, CAPAs, SSEs, QPLs, and other quality metrics, and assist in post - market surveillance complaint investigations. + **Risk Management:** Implement ... Senior Design Assurance Engineer Newark, DE, United States...medical devices throughout their lifecycle, from product development to post - market follow-up. Significantly contribute to assessing product… more
- Takeda Pharmaceuticals (Lexington, MA)
- …controls, manufacturing process validation, device product complaints, regular review of DHF, and post - market surveillance as related to on- market ... skills with a track record of supporting on- the market products and delivering new products to market...requests functional area action from the project teams to senior leaders in their functional area. + Has authority… more
- Orchard Therapeutics (Boston, MA)
- …real-time monitoring and benefit-risk assessment throughout the product lifecycle including post -marketing surveillance and post -approval commitments, + ... products to both internal and external stakeholders throughout the clinical development to market life cycle. This will be achieved using cost-effective, up to date,… more
- Leidos (Boston, MA)
- …support across USAF systems - Command, Control, Communications, Intelligence, Surveillance and Reconnaissance systems; strategic systems; and various specialized or ... solutions to the customer and maximize win probability. + Seek and utilize market intelligence and competitor data to position the division for ensuring success. +… more
- BAE Systems (Burlington, MA)
- …Systems Sector (ES), Command Control Communications Computers Intelligence Surveillance and Reconnaissance (C4ISR) Systems business area, Advanced Mission ... Solutions (AMS) Product Line is seeking a Senior Business Winning and Capture Team Leader. This hybrid...Capture Phases (Stages 2-4), Proposal Development (Stage 5) and Post -Submittal activities (Stage 6). + Manage and Coordinate Engineering… more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ Develop a clear implementation plan, agreed to by BD and QA senior leaders. + Resource planning and intra-QA coordination: maintain an up-to-date view of ... managing a Quality Management System and leading external QMS certification/ surveillance audits. + Thorough understanding of global submission requirements and… more
- Allied Universal (Boston, MA)
- …transforming the security industry. We integrate advanced technology - video surveillance , electronic access control, alarm monitoring and augmented solutions with ... for a designated territory, aiming to expand Allied Universal(R) Technology Services' market share across diverse industries + **Sales Process Management** : Oversee… more