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We are seeking an experienced Regulatory Affairs Specialist to join our team. · This role involves reviewing and maintaining supplier documentation for all raw materials, · creating and managing product specifications, · and ensuring compliance with applicable regulations. · ...
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We are seeking an experienced Regulatory Affairs Specialist to join our team. · This role involves reviewing and maintaining supplier documentation for all raw materials, creating and managing product specifications, and ensuring compliance with applicable regulations. · ...
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We are seeking an experienced Regulatory Affairs Specialist to join our team.This role involves reviewing and maintaining supplier documentation for all raw materials, · creating and managing product specifications, · and ensuring compliance with applicable regulations. · ...
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We are seeking an experienced Regulatory Affairs Specialist to join our team.This role involves reviewing and maintaining supplier documentation for all raw materials, · creating and managing product specifications, · and ensuring compliance with applicable regulations. · ...
Edison1 month ago
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We are seeking an experienced Regulatory Affairs Specialist to join our team.This role involves reviewing and maintaining supplier documentation for all raw materials, creating and managing product specifications, and ensuring compliance with applicable regulations. · ...
Edison1 month ago
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We are seeking an experienced Regulatory Affairs Specialist to join our team.This role involves reviewing and maintaining supplier documentation for all raw materials, · creating and managing product specifications, · and ensuring compliance with applicable regulations. · ...
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Mario Badescu Skin Care is seeking a Regulatory Affairs Specialist to serve as a key regulatory lead across our U.S. and global business. · ...
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· Company Description · Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, ...
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· Company Description · Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, ...
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This company is focusing on pushing the limits of innovation and supply in global health. · Supporting the preparation, review and correct submission of regulatory documentation for medical device/IVDs products ensuring compliance with all regulatory requirements including FDA, I ...
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Regulatory Affairs Specialist at Interparfums USA plays a crucial role in supporting the Regulatory Department by managing product registration across global markets. · This involves coordinating documentation, tracking registration statuses, and ensuring timely submissions to me ...
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This is a six-month contract position for a Regulatory Affairs Specialist to provide regulatory advice and risk assessment to Commercial Teams. The role involves providing innovative solutions and advice on promotional materials and ensure full regulatory compliance. · Provides r ...
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Company Description · ForDoz Pharma Corp. is a fully integrated pharmaceutical company specializing in addressing the unmet medical needs of sterile drug product development. Based in East Windsor, New Jersey, we focus on conventional sterile injectables and advanced technology p ...
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This is an ideal opportunity to have a positive impact on all the firm is doing. · ...
New York2 weeks ago
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Job Title: Regulatory Affairs Specialist II · Location: Princeton, NJ · Duration: 12 Months (Possible Extension) · Bachelor's Degree is required. 4-6 years of experience. · Job Description: · The essential duties and responsibilities include, but are not limited to the following: ...
Princeton $70,000 - $120,000 (USD) per year1 week ago
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Title: Regulatory Affairs Specialist II · Location: Princeton, NJ 08540 · Job Duration: 12 months Contract (Possibilities of contract extension) · Shift Schedule: 5 days a week in Princeton, NJ office (Normal business hours) · Responsibilities: · Utilize the Regulatory Informati ...
Princeton $70,000 - $120,000 (USD) per year1 week ago
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Job Title: Regulatory Affairs Specialist II · Location: Princeton, NJ · Duration: 12 months contract · Pay rate: $45-$53/hr. · Job Description: · Experienced professional who supports the development and execution of regulatory strategies with a strong focus on global complianc ...
Princeton $70,000 - $120,000 (USD) per year1 week ago
Regulatory Affairs Specialist - Bound Brook - Spectrum Vascular
1 day ago
Description
Regulatory Affairs Specialist
Spectrum Vascular is an innovative medical device company focused on vascular access and medication management to improve patient lives worldwide. Our mission is to provide caregivers with high quality products, exceptional customer service and innovation.
The Regulatory Affairs (RA) Specialist supports global regulatory submissions, ensuring medical devices meet applicable requirements throughout their lifecycle. This role collaborates cross-functionally with Quality, Engineering, Clinical and Manufacturing teams for filings like FDA 510(k), EU MDR Technical Documentation and Health Canada.
Key responsibilities include preparing, formatting and compiling regulatory submissions; supporting maintenance of files; responding to requests for additional information; assisting in U.S. and EU market approval processes; providing regulatory assessments for changes or product transfers.
The RA Specialist will also communicate with distributors about inquiries or filings support training initiatives related to compliance interpreting new regulations ensuring business practices align
Bachelor's degree in a scientific area (RAC certification preferred),1-3 years experience in regulated environments strong understanding of FDA,EU medical device regulations proficiency PC systems office applications solid understanding scientific principles applied regulatory affairs Spectrum Vascular Equal Opportunity Employer creating diverse inclusive culture-
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