Job Description

Regulatory Affairs Manager

📍 4 days on-site | Bedford, MA

💼 Medical Device Company – Commercial Stage

We’re seeking a Regulatory Affairs Manager to support U.S. and international regulatory activities as the company moves through commercialization and prepares for global expansion .

This position will collaborate closely with Quality, R&D, and senior leadership to manage regulatory submissions and documentation for Class II and Class III medical devices .

Key Responsibilities

• Prepare, submit, and maintain FDA 510(k), IDE, and PMA applications.
• Develop and update EU MDR (2017/745) technical documentation.
• Support MDSAP readiness and registration activities across multiple markets (Health Canada, TGA, ANVISA, PMDA).
• Ensure compliance during design control , change control , and risk management processes.
• Serve as a regulatory liaison with FDA and Notified Bodies .
• Contribute to ISO 13485 system improvements and post-market compliance activities.

Qualifications

• Experience preparing and managing medical device submissions (Class II or III).
• Strong understanding of FDA , EU MDR , and MDSAP requirements.
• Familiarity with ISO 13485 and design control documentation.
• Detail-oriented and organized, with the ability to manage multiple priorities in a collaborative environment.

This role offers the opportunity to contribute directly to the company’s regulatory strategy and gain visibility across all functions.

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