Description
Position Overview
Our client, a leader in the medical device industry, is hiring a Regulatory Affairs Specialist II. This is a growth opportunity for professionals with prior regulatory experience who are eager to advance their careers. The role provides pre-market and post-market regulatory support across U.S. FDA, Health Canada, EU, and other international regulatory bodies, while also taking ownership of departmental projects.
Key Responsibilities
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Lead and support U.S. FDA 510(k) submissions.
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Lead and support Health Canada device license applications.
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Prepare and manage EU technical files (both self-certified and notified body-reviewed).
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Support international device licensing and registration activities.
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Provide regulatory guidance to product development teams during new product submissions.
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Review and assess design changes for regulatory impact.
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Participate in and support internal and external quality system audits.
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Draft and review labeling to ensure compliance with U.S. and international regulatory requirements.
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Produce high-quality technical documentation and regulatory submissions.
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Lead departmental regulatory projects and coordinate activities across stakeholders.
Qualifications
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Experience with international product registrations.
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Experience authoring FDA 510(k) and Q-submissions.
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Experience with Class II and Class III Health Canada license applications.
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Experience with EU Class B and Class C IVDR submissions.
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Experience supporting ISO 13485 and MDSAP audits.
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Hands-on experience reviewing design changes for regulatory impact.
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Strong collaboration with R&D teams during product development.
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Quality system auditing experience preferred.
Skills & Competencies
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Excellent technical writing and documentation skills.
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Ability to lead multiple projects from initiation through completion.
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Strong problem-solving and communication skills.
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Proficiency in statistics and database management.
Education
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Bachelor’s degree in a scientific discipline required.
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Master’s degree in Regulatory Affairs preferred.