Full-Time
Regulatory Affairs Specialist
Spectrum Vascular
11-50 employees
Produces vascular-access devices to reduce infections
No salary listed
Warren, NJ, USA
Hybrid
Three days on-site per week required.
Bachelor's
 Legal & Compliance (1) |
|---|
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- A bachelor's degree in a scientific area is required.
- One to three years of experience in a regulated United States Food and Drug Administration environment, preferably with medical devices or combination products, is required.
- Hands-on experience with 510(k) submissions is required.
- A strong understanding of United States Food and Drug Administration and European Union medical device regulations is required.
- Strong organizational, communication, and planning skills are required.
- Proficiency with personal computer systems and office applications is required.
- A solid understanding of scientific principles applied to regulatory affairs is required.
- Assist in preparing, formatting, and compiling regulatory submissions, including Food and Drug Administration 510(k), European Union Medical Device Regulation technical documentation, Health Canada, and other global filings.
- Support the maintenance of regulatory files, declarations of conformity, and device listings and registrations.
- Support responses to regulatory agency requests for additional information, deficiency letters, and technical queries.
- Support United States and European Union market approval processes and ensure compliance with regulatory standards.
- Support post-market submissions, including progress reports and annual reports.
- Provide regulatory assessments for marketing, research and development, and manufacturing changes or product transfers.
- Communicate with distributors in response to requests for information and regulatory inquiries or in support of regulatory filings.
- Collaborate with Quality Assurance to ensure continued compliance with applicable regulatory standards, including Food and Drug Administration 21 CFR 820, ISO 13485, and European Union Medical Device Regulation 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, including regulatory letters, authorization letters, certifications, attestations, and technical packages for tenders and pre-market clearance.
- Communicate team and project progress, status, decisions, and timelines to other teams, departments, and executive leadership.
- Establish and maintain regulatory information systems.
- Contribute to continuous improvement initiatives and process optimization within Regulatory Affairs.
- Regulatory Affairs Certification is preferred.
- International regulatory experience is desirable.
- Internship or exposure to United States Food and Drug Administration, European Union Medical Device Regulation, or ISO regulatory environments is preferred.
- Knowledge of Investigational Device Exemption and Premarket Approval is a plus.
Spectrum Vascular makes vascular access and medication management devices. Its products include central venous catheters (CVCs), peripherally inserted central catheters (PICCs), midlines, arterial lines, and intraosseous needles designed to reduce infections and thrombus formation, with antimicrobial protection features like SV Spectrum and SV BioFlo. The company built its portfolio by acquiring Cook Medical’s vascular access lines in 2023 and AngioDynamics’ PICCs, midlines, and tip-location products in 2024, creating a broad platform for care across settings. Backed by private investors, Spectrum Vascular plans to grow through strategic leadership and expansion, aiming to lower infection risk and complications for patients and caregivers.
Company Size
11-50
Company Stage
N/A
Total Funding
N/A
Headquarters
White Plains, New York
Founded
N/A
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Simplify's Take
What believers are saying
- June 2026 Piccolo acquisition broadens guidance sales and cross-sell into Spectrum's catheter base.
- Spectrum's 2025 SK Capital recapitalization funds expansion and commercialization under Ken Miller.
- January 2025 Piccolo distribution already seeded hospital relationships before the June 2026 buyout.
What critics are saying
- FDA posted a March 2026 Class 2 recall for Spectrum Central Venous Tray expiration labeling.
- Cook-owned legacy products still carry recall risk, exposing Spectrum's inherited quality systems.
- BD launched CentroVena One in April 2026, compressing Spectrum's differentiation window.
What makes Spectrum Vascular unique
- SK Capital-backed Spectrum unites Cook, AngioDynamics, and Piccolo vascular access portfolios by June 2026.
- Piccolo's 510(k)-cleared blood-flow sensing navigation eliminates confirmatory chest X-rays.
- Ken Miller and Doug Shook bring KORU, ICU Medical, and BD vascular access expertise.
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Benefits
Remote Work Options
Health Insurance
Dental Insurance
Vision Insurance
Flexible Work Hours
Paid Vacation
Paid Holidays
401(k) Retirement Plan
401(k) Company Match
Stock Options
Company Equity
Wellness Program
Mental Health Support
Conference Attendance Budget
Professional Development Budget
Tuition Reimbursement
Growth & Insights and Company News
6 month growth
↑ 29%1 year growth
↑ 29%2 year growth
↑ 29%Spectrum Vascular has acquired Piccolo Medical, a developer of catheter guidance technology, to accelerate commercialisation of next-generation vascular access solutions. Piccolo CEO Augustus Shanahan will join Spectrum alongside his team to advance the company's 510(k)-cleared catheter guidance products. Piccolo's technology uses proprietary blood flow sensing to guide catheter tip placement in real time, eliminating the need for confirmatory chest X-rays. The company completed its first successful patient placements of the Nav+ Stylet in May 2026. Founded in 2016 and based in San Francisco, Piccolo was spun out of the Theranova medical device incubator. Spectrum Vascular, backed by SK Capital Partners, was formed through acquisitions of vascular access businesses from Cook Medical and AngioDynamics.
Spectrum Vascular acquires Piccolo Medical, accelerating launch of next-generation catheter navigation technology. More in financial: PR News WireThis post was originally published on this site WHITE PLAINS, N.Y., June 11, 2026 /PRNewswire/ - Spectrum Vascular ("Spectrum"), a leading provider of vascular access and medication management products, today announced the acquisition of Piccolo Medical ("Piccolo"), a developer of state-of-the-art catheter guidance products. The transaction deepens a partnership focused on bringing next-generation catheter guidance technology to market and marks a significant step forward in Spectrum's mission to deliver a complete, differentiated vascular access solution to the clinical community. Augustus Shanahan, CEO of Piccolo, will join Spectrum alongside the legacy Piccolo team. The group will advance development and commercialization of its 510(k)-cleared catheter guidance and location products, building upon an innovation roadmap more than a decade in the making. Piccolo's real-time catheter guidance utilizes proprietary blood flow sensing technology to precisely guide catheter tip placement, eliminating the need for confirmatory chest X-rays. Piccolo completed the first successful patient placements of its next-generation Nav+ Stylet in May 2026, marking the beginning of a new era in guided vascular access. "Joining the Spectrum team marks an exciting new chapter for Piccolo and for vascular access as a whole," said Augustus Shanahan. "I am incredibly proud of what the Piccolo team has built over the past decade, and together with Spectrum, we now have the platform, the portfolio, and the reach to set a new standard, delivering better outcomes for patients and real economic value for the hospitals that serve them." Kenneth Miller, CEO of Spectrum, commented, "The acquisition of Piccolo Medical represents an important milestone in our mission to transform vascular access. By combining Piccolo's breakthrough navigation technology with Spectrum's vascular access portfolio and commercial reach, we are uniquely positioned to accelerate innovation, improve patient care, and redefine the standard of care for clinicians worldwide." Together, Piccolo and Spectrum will accelerate commercialization, deepen integration with Spectrum's existing catheter portfolio, and scale the next-generation navigation platform. The combined organization is poised to set a new standard of care in vascular access with greater speed and reach. About Spectrum Vascular Spectrum Vascular, backed by SK Capital Partners, is a leading provider of vascular access and medication management products engineered to reduce healthcare-acquired infections. The Company's mission is to improve the lives of patients worldwide by providing caregivers with high quality, innovative products with exceptional customer service. Innovation has been a core strategic pillar throughout Spectrum's history and many of its products have been designed to deliver antimicrobial protection and thrombus reduction. Spectrum was formed through the acquisition of the vascular access businesses of Cook Medical and AngioDynamics. For more information, please visit www.spectrumvascular.com. About Piccolo Medical Piccolo Medical is a San Francisco-based medical device company and pioneer in catheter navigation and tip confirmation technology. Founded in 2016, Piccolo was spun out of the Theranova medical device incubator and has been funded through private investors as well as prestigious grant awards from The Eunice Kennedy Shriver National Institute of Child Health and Human Development. Piccolo is committed to developing and commercializing innovative vascular access technologies designed to improve clinical outcomes, streamline procedures, and reduce complications for patients. For more information, please visit www.piccolomedical.com. SOURCE Spectrum Vascular
Spectrum Vascular, a NYC-based medical device company, received an undisclosed investment from SK Capital Partners. The funds will be used to expand operations and development efforts. Spectrum Vascular, founded in 2023, specializes in vascular access and medication management products and was formed through the acquisition of the vascular access businesses of Cook Medical in 2023 and AngioDynamics in 2024.
SAN FRANCISCO, Jan. 13, 2025 /PRNewswire/ - Piccolo Medical(R), an emerging leader in catheter navigation devices for vascular access procedures, is proud to announce an exclusive distribution agreement with Spectrum Vascular(TM), a leading provider of vascular access and medication management products designed to reduce healthcare acquired infections ("HAI").