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...Job Description: · With minimal supervision, the Regulatory Affairs Expert-Medical Devices manages assigned regulatory tasks related to... ...with requirements of FDA 21 CFR 820, CMDR SOR 98-292, ISO 13485:2016, and other applicable International Medical Device Regulations....
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...Job title: CMC Regulatory Technical Writer II
Location: Bridgewater, NJ, Hybrid
Duration... ...authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations...
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Contract work
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...Global Regulatory Affairs Lead (GRL)
Mission statements
The Global Regulatory Affairs Lead (GRL) is the fully accountable decision... ...GRL is accountable for ensuring alignment and communication internally and externally as “one GRA voice” with TA, GBU Head and up to...
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...responsibilities of the position are to drive improvements in regulatory affairs processes, systems and infrastructure whilst supporting... ...develop strong working relationships within RA group as well as internal/external customers.
Regulatory Affairs Specialist work...
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Work from home
Night shift
2 days per week
1 day per week
...Scope
To support business in maintaining regulatory compliance of existing manufactured... ...Responsibilities (Approx. 60 80% of Time):
Advising internal and external stakeholders of the likely... ...knowledge of the Global Regulatory Affairs environment Guidelines and legislation....
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...Responsibilities:
Prepares regulatory strategies and maintains submissions for U.S. and International markets, including but not limited to 510(k)s and Technical... ...of experience in medical device Regulatory Affairs with RAC certification or 3 years of...
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...Responsibilities:
Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives.
Creates, reviews, and approves engineering changes.
Acts as core team member providing...
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...Regulatory Affairs Specialist
Newark, DE, United States
Hologic is seeking a Regulatory Affairs Specialist to join our expanding Innovation... ...with company policies from all areas of company as well as internal audits and inspections. We expect the Regulatory Affairs...
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Local area
...We have an exciting opportunity at Ameriprise as a Regulatory Affairs Analyst! This position is part of a team that provides day-to-day operational... ...Affairs team in managing regulatory exams, inquiries and internal investigations. This includes matter intake, production...
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...currently have an exciting opportunity available for a Manager, Regulatory Affairs in Boca Raton, FL !
The Manager, Regulatory Affairs... ...of potential regulatory impact and implements appropriate internal changes. Contributes to the development of company policy and...
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Full time
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Immediate start
Remote job
Shift work
...Regulatory Affairs Specialist
Monday - Friday, 8:30 am - 5:00 pm
About Us
At Argen, we're in the business of creating healthy,... ...inspections in compliance with local, state, national and international regulatory requirements.
In this role, the successful candidate...
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Local area
Worldwide
Monday to Friday
...Job Description:
The Regulatory Affairs Specialist will be responsible for establishing, coordinating, and executing user experience... ...clinical evaluations. This position establishes and manages internal systems to ensure that clinical evaluations meet all applicable...
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Contract work
3 days per week
...advancement of eye health in the future.
Objectives:
The Regulatory Affairs Manager handles all regulatory development aspects of... ...Provide regulatory guidance/input to device change control and internal product review boards.
* Manage assigned personnel.
* Other...
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Holiday work
Work visa
...Responsibilities:
Develop global regulatory strategies for medical device products... ....
Maintenance of Regulatory Affairs product files and ensure compliance... ...IVDR, Korea MFDS, China NMPA and other international medical requirements....
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...difference in patients' lives.
Position Summary
The Regulatory Affairs Specialist will develop strategies and submissions for projects... ...a plus.
* Regulatory affairs experience in domestic and international submissions, with 2-3 years of overall class I or II...
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Worldwide
...Review labels of private label products for regulatory compliance in the US and applicable international markets. Review list of ingredients for accuracy, and inclusion of all required use instructions, warnings, symbols, etc. Collect/coordinate info Regulatory, Specialist...
...and tools for precision health.
Health regulatory policy is dynamic and multi-faceted, requiring... ...AI. The Scientific and Regulatory Affairs team of Health Futures is seeking a Healthcare Regulatory and Policy research intern to review and synthesize developments in...
Internship
Summer work
...The Regulatory Affairs Specialist is responsible for working as part of project teams with product development and manufacturing management... ...between their organization and state, local, federal, and international agencies. Including communicate on pre-submission...
Local area
...Regulatory Affairs Analyst at Highmark Health in Boise, Idaho, United States Job Description Company : Highmark Inc. Job Description : JOB... ...maintains third party relations with delegated vendors and internal business units to ensure oversight of delegated business is...
...for great talent to join our team!
We are looking for a Regulatory Affairs Associate to join the regulatory team, which works across all... ...approvals.
Lead the formulation and implementation of internal company processes and protocols to ensure alignment with regulatory...
Worldwide
