Job Description

Position Objective:

The Senior Regulatory Affairs Specialist is responsible for developing regulatory strategies, managing submissions, and securing product approvals globally. They also assess regulatory impacts of device changes and mentor junior staff.

Key Responsibilities:

• Develop regulatory strategies and submissions (e.g., 510(k), IDE, EU/CE, international registrations).
• Collaborate with global teams to ensure compliance and address regulatory queries.
• Review and negotiate product submissions for timely approvals.
• Support marketed products, including labeling and promotional material reviews.
• Assist with regulatory compliance, registrations, and audits.
• Maintain global regulatory knowledge and relationships with agencies.
• Guide junior staff and ensure adherence to quality systems.

Qualifications:

• Bachelor’s degree with 4+ years of regulatory experience, or an advanced degree with 2+ years.
• Experience with FDA Class II/III or EU Class IIb/III devices.
• Strong project management, communication, and collaboration skills.
• Ability to manage multiple tasks and lead regulatory projects.

Preferred:

• Experience with Health Canada Class 3/4 devices, international submissions, or cardiovascular devices.

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