What are the responsibilities and job description for the Regulatory Affairs Manager position at Pragmatic?
Regulatory Affairs Manager
đź“Ť 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.
Salary : $155,000 - $175,000