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Must Haves:
• Must have Medical Device experience. (Not Pharma)
• European MDR Experience
• Manufacturing background
• 4 Years of experience minimum (pure medical devise)
Job Description:
• Support the NBL Manager in Lifecycle Change Management projects.
• Pro-actively interacting with Site Regulatory Assessors on Change Notifications, providing a high standard of regulatory support, review and approval of applications with the demonstrated ability to act independently to execute to foster and drive right first-time submissions.
• Driving on-time processing, submission, and oversight of Change Notification submissions to support Alcon business needs, to project completion.
• Maintaining in-house tracking tools to track NB submissions for all Notified Body projects.
• Support the maintenance of Product and QS EC Certificates (MDD /MDR) and associated documentation.
• Assist with the coordination and scheduling of NB meetings for Alcon SMEs as required, including documenting and filing of NB meeting minutes.
• Support NBL team and Alcon QMS in coordination and execution of NB audits.
• Collaborate with the MDR PMs, GRA strategists and cross- functional teams to support MDR Sub. Strategy and implementation timelines.
• Support the NB Budget process and processing of NB financial invoicing.
• Actively contribute to the delivery of internal training and guidance to Site Regulatory Assessors on EU Medical Device Significant Change Notification reporting requirements
• Support the implementation of project related "regulatory excellence" activities as part of QS continuous improvement initiatives.
Full Time
$105k-134k (estimate)
06/15/2024
07/02/2024
eteaminc.com
SOUTH PLAINFIELD, NJ
500 - 1,000
1999
Private
BIPIN TAHKUR
$50M - $200M
IT Outsourcing & Consulting
eTeam provides industry-specific, SOW-based services, and global contingent workforce managementsolutions.
The following is the career advancement route for Regulatory Affairs Specialist positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Specialist, it can be promoted into senior positions as a Regulatory Affairs Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Affairs Specialist. You can explore the career advancement for a Regulatory Affairs Specialist below and select your interested title to get hiring information.