Hybrid Regulatory Affairs Manager

at Spectrum Vascular

• Job title: Regulatory Affairs Manager
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Bridgewater, United States

About the role

• Regulatory Affairs Manager at Spectrum Vascular focusing on regulatory strategies and compliance for FDA and international medical devices. Collaborating with cross-functional teams to ensure timely submissions and approvals.

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.

Requirements

• 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.
• Advanced Degree preferred.
• 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.

Benefits

• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Travel – up to 25%??, additional may be required during execution of validation activities