What you will be doing:
* Provide regulatory support to the Development and Post marketing activities related to our products.
* Preparation and maintenance of regulatory submissions and registrations of our products in relevant markets.
* Review complex reports, validations, etc. for scientific merit and regulatory appropriateness; Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
* Preparation and maintenance of annual renewals of Establishment Registrations, Device Listing, and other pertinent regulatory licenses.
* Review of customer complaints to determine reportability according to regulatory requirements and execution of reporting per determination.
* Provide ongoing regulatory support and assessments to different QMS related processes (e.g. MRB, CAPA, Contract review)
* Actively participate in the evaluation of changes to the QMS documents and device design/process for impact on pending or existing registrations
* Provide support for all external/internal audits at HQ and globally, as needed
* Advise project teams on premarket regulatory requirements, labeling requirements and/or other compliance issues.
* Work closely with various other teams (e.g. R&D, Operations, Quality, Marketing) both locally and around the world, to provide regulatory inputs as needed.
* Monitor and advise the organization of upcoming or new guidance, regulations, agency/industry initiatives, etc. to ensure ongoing regulatory compliance
* Attend other regulatory related needs, as required
* Working according to our Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.
* Provide regulatory support to the Development and Post marketing activities related to our products.
* Preparation and maintenance of regulatory submissions and registrations of our products in relevant markets.
* Review complex reports, validations, etc. for scientific merit and regulatory appropriateness; Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
* Preparation and maintenance of annual renewals of Establishment Registrations, Device Listing, and other pertinent regulatory licenses.
* Review of customer complaints to determine reportability according to regulatory requirements and execution of reporting per determination.
* Provide ongoing regulatory support and assessments to different QMS related processes (e.g. MRB, CAPA, Contract review)
* Actively participate in the evaluation of changes to the QMS documents and device design/process for impact on pending or existing registrations
* Provide support for all external/internal audits at HQ and globally, as needed
* Advise project teams on premarket regulatory requirements, labeling requirements and/or other compliance issues.
* Work closely with various other teams (e.g. R&D, Operations, Quality, Marketing) both locally and around the world, to provide regulatory inputs as needed.
* Monitor and advise the organization of upcoming or new guidance, regulations, agency/industry initiatives, etc. to ensure ongoing regulatory compliance
* Attend other regulatory related needs, as required
* Working according to our Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.
Requirements:
What you have:
* BSc. degree in scientific / technical discipline / engineering.
* A minimum of 4 years of Regulatory Affairs experience with the US FDA and EU regulatory agencies (Class II and/or Class III medical devices)
What you have:
* BSc. degree in scientific / technical discipline / engineering.
* A minimum of 4 years of Regulatory Affairs experience with the US FDA and EU regulatory agencies (Class II and/or Class III medical devices)
Advantages:
* RAPS RAC (Medical Device)
* Advanced degree.
This position is open to all candidates.
