Regulatory Affairs Consultant II — Medical Devices

ECI; Marlborough (MA); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

ECI is seeking a Regulatory Affairs Consultant II to support medical device regulatory activities across client projects. You will collaborate with cross-functional teams to manage changes, prepare submissions, and ensure compliance throughout product lifecycles.

The role emphasizes contributing to post-market activities and regulatory strategy development. Candidates should have five+ years in Regulatory Affairs for medical devices, strong leadership, multitasking ability, and solid regulatory

Qualifications

• Five+ years of directly related Regulatory Affairs experience in medical devices.
• Ability to organize, lead, participate, and facilitate a team to produce results.
• Capacity to multi-task multiple projects in a fast-paced environment.
• Strong analytical, troubleshooting, decision-making, and communication skills.
• Proven regulatory planning and strategy experience (510(k)/IDE/PMA).

Responsabilités

• Provide regulatory support for device changes and 510(k) activities.
• Lead day-to-day regulatory change assessments and support Letters to File.
• Prepare and coordinate 510(k) submissions for devices.
• Support multiple devices and ongoing maintenance initiatives.
• Interact with cross-functional teams for US/International submissions and design reviews.
• Contribute to risk management, plans, and project reviews.
• Support Post Market Surveillance activities including CAPA and recalls.
• Ensure FDA/ISO/EU MDR compliance documentation.
• Identify regulatory obstacles and develop cross-team solutions.

Connaissances

Regulatory affairs

Project leadership

Multitasking

Analytical skills

Regulatory planning

Description du poste

ECI is seeking a Regulatory Affairs Consultant II to support medical device regulatory activities across client projects. You will collaborate with cross-functional teams to manage changes, prepare submissions, and ensure compliance throughout product lifecycles.

The role emphasizes contributing to post-market activities and regulatory strategy development. Candidates should have five+ years in Regulatory Affairs for medical devices, strong leadership, multitasking ability, and solid regulatory