Regulatory Affairs Specialist (Hybrid)

Spectrum Vascular•Bridgewater, NJ

3d•Hybrid

About The Position

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. dThe 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.

Requirements

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

Responsibilities

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