Spectrum Vascular · 3 months ago
Regulatory Affairs Manager (Hybrid)
Hybrid - Bridgewater NJ
Full-time
Hybrid
Senior Level
5+ years expSpectrum Vascular is an innovative medical device company focused on improving patient lives through high-quality products. The Regulatory Affairs Manager will implement regulatory strategies, manage product registrations, and ensure compliance for medical devices in the US and globally.
ManufacturingMedical Device
Responsibilities
Act as a primary contact for regulatory affairs on cross-functional product development and post-marketing teams and support submission activities throughout product development and lifecycle
Manage and work with minimal supervision to help bring medical devices to market and ensure ongoing Regulatory Affairs compliance
Participate on cross-functional teams and develop US and global regulatory strategies
Author regulatory submissions, interact with regulatory agencies/notified bodies, review labelling and marketing materials, and evaluate proposed device changes
Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies. Work independently to evaluate regulatory issues and revise technical documentation for existing and new regulatory submissions
Anticipate and manage regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions
Provide regulatory input and technical guidance for product development and planning throughout the product lifecycle
Assess the acceptability of quality, preclinical, and clinical documents for submissions to comply with applicable regulations
Evaluate proposed changes for regulatory submissions and propose strategies for changes that do not require submissions
Author draft submissions (510k, PMA, BLA) with minimal supervision. Ensure timeliness of regulatory submissions according to business needs including ensuring prompt follow-up to the questions and requests received from regulators
Under minimal supervision, assist with the coordination, preparation, and maintenance of FDA 510K filings in accordance with US FDA requirements. Interact with Regulatory Body personnel in collaboration with the Chief Operating Officer/ Sr. VP Regulatory Affairs
Support the regulatory aspects of upcoming audits and certification reviews with all Company designated Notified Bodies. Communicate with the Company’s Notified Bodies regarding regulatory issues/questions and schedule Technical Documentation/Technical File reviews
Develop regulatory strategies around ad/promo reviews based on regulations; review promotional and advertising material for adherence to approved product claims and regulatory compliance
Serve as RA lead and work with cross-functional management to review and approve rework of non-conforming product CAPA, SCAR, HHE and Field Actions. Support product risk management in accordance with FDA/ISO 14971
Work independently or with minimal supervision to review complex Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval to ensure compliance with government regulations
Work independently to contribute to establishing labeling requirements per regulations and review labeling that requires regulatory review and approval to ensure compliance with government regulations
Participate in and lead continuous improvement projects within Regulatory Affairs and throughout the organization, as assigned
Contribute to the authoring of SOPs and train key personnel as needed
Perform other duties as assigned
Qualification
Required
A Bachelor's Degree (B.S or B.A) in Engineering, Science or equivalent focus is required
A minimum of 5 years of experience in an FDA-regulated industry required; preferably with medical devices
Previous experience with submitting 510ks and/or PMAs required
Strong understanding of product development process and design control
Thorough understanding of FDA and international medical device regulations
Strong knowledge of FDA medical device Regulatory Affairs requirements
Experience interacting with Regulatory Agencies and Notified Bodies required
Excellent scientific written and verbal communication skills
Advanced PC skills with proficiency in Microsoft office Suite, including Excel
Preferred
Advanced Degree preferred
Company
Spectrum Vascular
Spectrum Vascular's aim is to make patients' lives better all around the world by offering caregivers innovative, high-quality products.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknownKey Investors
SK Capital Partners
2025-03-31Private Equity
2025-03-31Debt Financing
Leadership Team
Sharon Klugewicz
Chief Operating Officer
Recent News
Medical Product Outsourcing
2025-05-03
2025-04-15
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