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The position supports the Medical Affairs function for Atrium Professional brands of Client Health Science. · Evaluates cumulative body of research to substantiate dietary supplement product claims · Develops education to support new and existing dietary supplement products in US ...
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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. · ...
Edison2 weeks 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. · ...
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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Lensa is a career site that helps job seekers find great jobs in the US. We are not a staffing firm or agency. · We are seeking an experienced Regulatory Affairs Specialist to join our team.This role involves reviewing and maintaining supplier documentation for all raw materials, ...
Edison1 month ago
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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, ...
Bridgewater, NJ $90,000 - $145,000 (USD) per year5 days ago
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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, ...
Bridgewater, NJ5 days ago
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This Regulatory Affairs Specialist contractor position supports US Beverages Regulatory Affairs initiatives. · The primary focus of this position is to support graphic refreshes of the Beverages portfolio which includes the development of the nutrition and ingredient label declar ...
New York1 month ago
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We are looking for a detail-oriented Regulatory Affairs Specialist to join our team in Valhalla. The ideal candidate will possess a solid understanding of regulatory requirements ensuring our products meet all necessary guidelines. · ...
New York1 month ago
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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 ...
Summit1 month ago
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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 ...
New York $70,000 - $120,000 (USD) per year1 day ago
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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 ...
New York1 month ago
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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 ...
East Windsor $70,000 - $120,000 (USD) per year5 days 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 year6 days 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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This is an ideal opportunity to have a positive impact on all the firm is doing. · ...
New York2 weeks ago
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As a Civil Affairs Specialist, you'll be the link between the Army and local civilians around the world. You will identify what critical resources local citizens may need during missions or in crisis situations, fostering and maintaining dialogue with civilian aid agencies and ci ...
York Full time22 hours ago
Regulatory Affairs Specialist - Bound Brook - Spectrum Vascular
Description
Regulatory Affairs Specialist (Hybrid)
Spectrum Vascular is an innovative medical device company focused on vascular access and medication management. Our mission is to improve the lives of patients worldwide by providing caregivers with high quality, innovative products with exceptional customer service. We are a company that was formed through the acquisition of a portfolio of trusted products that have been widely used by customers for decades. Innovation has been a core strategic pillar throughout our history and many of our products have been designed to deliver antimicrobial and antithrombogenic protection or to support certain patient populations such as those who are critically ill and pediatrics. This role represents a unique opportunity to join a dynamic and growing team with established products and an entrepreneurial mindset.
The Regulatory Affairs (RA) Specialist is responsible for supporting global regulatory submissions and compliance activities to ensure medical device products meet applicable regulatory requirements throughout their lifecycle. This role collaborates cross-functionally with Quality, Engineering, Clinical, and Manufacturing teams to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities.
Assist in the preparation, formatting, and compilation of regulatory submissions (e.g., FDA 510(k), EU MDR Technical Documentation, Health Canada, and other global filings)
Support the maintenance of regulatory files, declarations of conformity, and device listings/registrations.
Support responses to regulatory agency requests for additional information (AIs, deficiency letters, technical queries).
Support U.S. and EU market approval processes and ensure compliance with regulatory standards
Support post-market submissions (progress reports, annual reports, etc.)
Provide regulatory assessments for marketing, R&D, and manufacturing changes or product transfers
Communicate with distributors in response to requests for information, regulatory inquiries or in support of regulatory filings.
Collaborate with Quality Assurance to ensure continued compliance with applicable regulatory standards, including FDA 21 CFR 820, ISO 13485, and EU MDR 2017/745.
Participate in internal audits, management reviews, and external audit preparations as needed.
Support document control and recordkeeping to ensure regulatory documentation integrity and traceability.
Work closely with Quality, Engineering, and Clinical teams to gather information needed for submissions and documentation.
Assist in preparing summaries, tracking deliverables, and ensuring timely submission of regulatory documents.
Support training and awareness initiatives related to regulatory compliance.
Interpret new or existing regulations and ensure business practices align with compliance requirements
Create documentation in response to customer regulatory requests which includes regulatory letters, authorization letters, certifications, attestations, technical packages, etc. for tenders and for pre-market clearance.
Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to other teams/departments and executive leadership.
Establish and maintain regulatory information systems
Contribute to continuous improvement initiatives and process optimization within RA
Bachelor's degree in a scientific area (RAC certification preferred)
1-3 years of experience in a regulated FDA environment (medical devices or combination products)
Hands-on experience with 510(k) submissions (IDE and PMA knowledge a plus)
Strong understanding of FDA and EU medical device regulations (international experience desirable)
Internship or exposure to FDA, EU MDR, or ISO regulatory environments preferred. Strong organizational, communication, and planning skills
Proficiency with PC systems and office applications
Solid understanding of scientific principles applied to regulatory affairs
Spectrum Vascular is an Equal Opportunity Employer and committed to creating a diverse and inclusive company culture. Spectrum Vascular does not discriminate against candidates and employees because of their disability, sex, race, gender identity, sexual orientation, religion, national origin, age, veteran status, or any other protected status under the law.
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