Regulatory Affairs Specialist
4 weeks ago
Through coordination/collaboration with direct supervisor and with routine direction and guidance, review and remediate regulatory documentation in support of market clearance/approval. Ensures regulatory compliance of technical documentation in local PLM system and corresponding product registrations with FDA and EU Notified Body. Maintains databases as required. Supports regulatory compliance projects as assigned.
Responsibilities:
- Maintains current knowledge of the development and changes to applicable laws, regulations and industry standards for global markets, providing guidance in interpreting regulations and agency guidelines.
- Initiates, reviews and approves technical documentation, product labeling, and product instructions for use changes for compliance with applicable regulations. Trains to and executes document management within local Product Lifecycle Management system and other electronic documentation systems as applicable.
- Updates and maintains product registrations with US FDA and EU Notified Body to assure compliance with applicable global regulatory requirements.
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Junior Regulatory Affairs Specialist
6 days ago
Andover, United States Randstad North America, Inc. Full timeA Junior Regulatory Affairs Specialist is needed for a medical technology company focused on the repair, regeneration and replacement of soft and hard tissue in the Andover, MA area. This role involves coordinating with a supervisor to ensure regulat Regulatory Affairs, Specialist, Regulatory, Junior, Business Services, Staffing, Compliance
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Junior Regulatory Affairs Specialist
4 days ago
Andover, Massachusetts, United States Randstad USA Full timejob summary: A Junior Regulatory Affairs Specialist is needed for a medical technology company focused on the repair, regeneration and replacement of soft and hard tissue in the Andover, MA area. This role involves coordinating with a supervisor to ensure regulatory compliance and documentation for market clearance, maintaining databases, updating product...
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Junior Regulatory Affairs Specialist
3 days ago
Andover, United States Randstad USA Full timejob summary: A Junior Regulatory Affairs Specialist is needed for a medical technology company focused on the repair, regeneration and replacement of soft and hard tissue in the Andover, MA area. This role involves coordinating with a supervisor to ensure regulatory compliance and documentation for market clearance, maintaining databases, updating product...
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Product Safety
3 days ago
Andover, United States ICP Group Full timeJob DescriptionJob DescriptionInnovative Chemical Products Group (ICP Group) is a leading formulator and manufacturer of specialty coatings, adhesives, and sealants serving the construction and industrial end markets. ICP Group is comprised of market leading brands known for innovation, quality, and performance. ICP Group has scaled rapidly through organic...
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Product Safety
4 days ago
Andover, United States ICP Group Full timeInnovative Chemical Products Group (ICP Group) is a leading formulator and manufacturer of specialty coatings, adhesives, and sealants serving the construction and industrial end markets. ICP Group is comprised of market leading brands known for innovation, quality, and performance. ICP Group has scaled rapidly through organic and acquisition growth into one...
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Regulatory Affairs Specialist
1 week ago
Andover, United States Integration International Inc. Full timeDescription:Role Overview -Include specific internal and external relationships, product focus, regulatory requirements, physical demands, etc.Through coordination/collaboration with direct supervisor and with routine direction and guidance, review and remediate regulatory documentation in support of market clearance/approval. Ensures regulatory compliance...
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Regulatory Affairs Specialist
1 week ago
Andover, United States ProKatchers LLC Full timeJob Summary:include specific internal and external relationships, product focus, regulatory requirements, physical demands, etc.Through coordination/collaboration with direct supervisor and with routine direction and guidance, review and remediate regulatory documentation in support of market clearance/approval. Ensures regulatory compliance of technical...
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Regulatory Affairs Specialist
1 week ago
Andover, United States Integration International Inc. Full timeDescription:Role Overview -Include specific internal and external relationships, product focus, regulatory requirements, physical demands, etc.Through coordination/collaboration with direct supervisor and with routine direction and guidance, review and remediate regulatory documentation in support of market clearance/approval. Ensures regulatory compliance...
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Regulatory Affairs Specialist
1 week ago
Andover, United States Integration International Inc. Full timeDescription:Role Overview -Include specific internal and external relationships, product focus, regulatory requirements, physical demands, etc.Through coordination/collaboration with direct supervisor and with routine direction and guidance, review and remediate regulatory documentation in support of market clearance/approval. Ensures regulatory compliance...
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Regulatory Affairs Specialist
6 days ago
Andover, United States Integration International Inc Full timeDescription: Role Overview - Include specific internal and external relationships, product focus, regulatory requirements, physical demands, etc. Through coordination/collaboration with direct supervisor and with routine direction and guidance, review and remediate regulatory documentation in support of market clearance/approval. Ensures regulatory...
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Regulatory Affairs Specialist
1 week ago
Andover, United States ProKatchers LLC Full timeJob Summary:include specific internal and external relationships, product focus, regulatory requirements, physical demands, etc.Through coordination/collaboration with direct supervisor and with routine direction and guidance, review and remediate regulatory documentation in support of market clearance/approval. Ensures regulatory compliance of technical...
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Regulatory Affairs Specialist
6 days ago
Andover, United States ProKatchers Full timeJob Summary: include specific internal and external relationships, product focus, regulatory requirements, physical demands, etc. Through coordination/collaboration with direct supervisor and with routine direction and guidance, review and remediate regulatory documentation in support of market clearance/approval. Ensures regulatory compliance of technical...
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Manager, Regulatory Affairs
5 days ago
North Andover, United States Fresenius Kabi USA, LLC Full timeJob Summary The Manager, Regulatory Affairs is responsible for defining and implementing regulatory strategies and submissions in support of new and existing market authorizations. Participate on cross-functional project teams and act as global regulatory advisor. This position will be supporting Infusion Systems within Regulatory Affairs. ** This is a...
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Regulatory Affairs Labeling Specialist
6 days ago
Andover, United States JobRialto Full timeDescription: Laptop will not be issued. Operates complex equipment and analytical tools, processes, state of the art 12'' silicon wafers in a clean room environment, which requires appropriate gowning. Technicians are owned in a gore suit that covers them from head to toe as they perform their work duties. Multi-tasked responsibilities may include minor...
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Program Manager Product Development
2 weeks ago
Andover, United States TransMedics Full timeReporting directly to the Senior VP of Disposable Products Development, the Program Manager of Product Development will lead teams responsible for the overall execution of critical business programs from concept development through manufacturing transfer and commercialization. Responsibilities will include management of disposable and capital equipment...
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Program Manager, Product Development
2 weeks ago
Andover, United States TransMedics Full timeReporting directly to the Senior VP of Disposable Products Development, the Program Manager of Product Development will lead teams responsible for the overall execution of critical business programs from concept development through manufacturing transfer and commercialization. Responsibilities will include management of disposable and capital equipment...
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Program Manager
2 days ago
Andover, United States Connexion Systems & Engineering, Inc. Full timeJob DescriptionJob DescriptionProgram Manager, Product Development - Medical Devices(On-site, not Hybrid or Remote)No H1B...
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Program Manager Product Development
2 weeks ago
Andover, United States TransMedics, Inc. Full timeReporting directly to the Senior VP of Disposable Products Development, the Program Manager of Product Development will lead teams responsible for the overall execution of critical business programs from concept development through manufacturing transfer and commercialization.Responsibilities will include management of disposable and capital equipment...
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Program Manager Product Development
1 month ago
Andover, United States TransMedics, Inc. Full timeReporting directly to the Senior VP of Disposable Products Development, the Program Manager of Product Development will lead teams responsible for the overall execution of critical business programs from concept development through manufacturing transfer and commercialization.Responsibilities will include management of disposable and capital equipment...
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Program Manager Product Development
1 month ago
Andover, United States TransMedics, Inc. Full timeReporting directly to the Senior VP of Disposable Products Development, the Program Manager of Product Development will lead teams responsible for the overall execution of critical business programs from concept development through manufacturing transfer and commercialization.Responsibilities will include management of disposable and capital equipment...