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...the preparation and maintenance of domestic and international regulatory filings to meet corporate objectives and for the timely completion... ...education and applicable work experience.
* Regulatory Affairs Certificate, preferred.
* Certification (RAC) by the Regulatory...
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...The Sr. Regulatory Affairs Specialist will lead activities which support both domestic and international regulatory registrations and submissions activities including data and information analysis. Additionally, the ideal candidate will provide regul Specialist, Medical...
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...device products in the US and in foreign countries.
Serves as a regulatory liaison for new product development and make regulatory... ...department.
May oversee and direct the work of other Regulatory Affairs professionals.
The job function listed is not exhaustive...
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...registrations and submissions (510(k), PMA) to FDA and other regulatory bodies.
Maintains company registrations and device listings... ...preferred.
Minimum five (5) years of experience in Regulatory Affairs.
Knowledge and Abilities:
Proficient knowledge of...
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Apply for Sr. Regulatory Affairs Specialist
LimFlow is searching for an experienced and highly motivated Sr. Regulatory Affairs Specialist for to support Class II and Class III regulatory filings in the United States and select international markets. In this critical position...
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...Description
The Sr. Regulatory Affairs Specialist works under minimal supervision supporting cross- functional teams with regulatory strategy and execution for new devices and device modifications.
Responsibilities
Participate as the regulatory representative...
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...for the compilation and submission of regulatory documentation to global Health Agencies... ...Primary responsibilities for the Regulatory Affairs Specialist role:
* Manages dossier compilation... ...in biopharmaceutical industry.
Sr. Regulatory Affairs Specialist I
* Bachelor...
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...providers an array of medical technology solutions that make a difference in patients' lives.
Position Summary
The Regulatory Affairs Specialist will develop strategies and submissions for projects and issues related to regulatory documents, global submissions,...
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...Job title: CMC Regulatory Technical Writer II
Location: Bridgewater, NJ, Hybrid
Duration: 1 year
SHIFT SCHEDULE 1st shift... ...functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations or contract manufacturing...
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...investments in Endoscopy treatments, both within established product lines as well as in future pipelines.
The Senior Regulatory Affairs Specialist will provide regulatory support on a range of Endoscopy devices and activities which include new product introduction,...
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...lives. We are looking for individuals who share this passion to join our team.
We currently have an opening for a Sr. Regulatory Affairs Specialist supporting the Cardiac Surgery product area. This position is responsible for activities which lead to and maintain regulatory...
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Nova Biomedical is hiring a Regulatory Affairs Specialist (Level II or Senior Level) in our Waltham, MA facility (Hybrid) to focus on assuring company... ...Affairs is preferred
~2+ years (Level II) or 3+ years (Sr. Level) IVD or medical device experience
~ Previous...
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...Job Title
Sr. Regulatory Affairs Specialist-CT/AMI
Job Description
The Senior RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving...
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...world class manufacturing and lab facilities. Come Join Our Team!
Description
Coltene has an opening for a Sr. Regulatory Affairs Specialist to join our Regulatory team at our Cuyahoga Falls, Oh site location.
The Senior Regulatory Affairs Specialist shall...
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...assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle... ...applications.
Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to...
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Overview:
Under supervision and direction of the Regulatory Affairs Manager, this position assists in supporting the plan-wide HIPAA program and Fraud, Waste, and Abuse (FWA) program and acts as a liaison between the plan and our regulatory agencies. This position coordinates...
...and who share a common goal of getting our technology into every physician’s office. We have a great opportunity for a Regulatory Affairs Specialist to join our team!
ABOUT THE ROLE
The Regulatory Affairs Specialist will assist in regulatory submissions, interpret...
Flexible hours
...Regulatory Affairs Specialist
The Regulatory Affairs Specialist ensures product safety and legal compliance regarding global chemical regulations in product development across the supply chain. Responsibilities include providing product stewardship support regarding...
...Provides regulatory support to meet department and corporate objectives for both on-going business and new product development. Work emphasizes... ...and state level as well as OSHA regulated products, and Extended Regulatory, Specialist, Technical, Manufacturing, Healthcare...
...Regulatory Affairs Specialist
Full Time
San Diego, CA, US
Salary Range: $90,000.00 To 110,000.00 Annually
Monday – Friday, 8:30 am – 5:00 pm
Who we Are:
A global leader in dental manufacturing with headquarters in San Diego, CA, subsidiaries in Canada...
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