Manager of Engineering Quality & Regulatory Affairs at 3DISC in Herndon, Virginia

Job Description:

Company: 3DISC

Location: Herndon, VA - 100% On-site (Local candidates only, please)

About 3DISC:
3DISC is a global leader in the design and manufacturing of state-of-the-art intraoral scanners for the dental industry. Our commitment to technological innovation has propelled us to the forefront of the market, providing dental professionals with advanced imaging solutions for precise diagnostics and treatment planning.

Position Overview:
We are seeking a Manager of Engineering Quality & Regulatory Affairs to oversee engineering quality, design controls, and regulatory compliance for our cutting-edge intraoral scanners. This role is 100% on-site in Herndon, VA, and requires a local candidate with strong experience in medical device quality management and regulatory affairs.

Key Responsibilities:
1. Design Controls & Compliance:

• Oversee the implementation and maintenance of robust design control processes.
• Ensure compliance with FDA 21 CFR 820, ISO 13485, EU MDR, and other relevant medical device regulations.
• Collaborate with cross-functional teams to integrate risk management and verification/validation into engineering processes.

2. Regulatory Affairs:

• Lead regulatory submissions (510(k), CE Marking) and maintain global registration portfolios.
• Communicate with regulatory agencies and notified bodies to ensure approvals and compliance.
• Stay current with evolving global medical device regulations and implement necessary updates.

3. Engineering Quality & Remediation:

• Develop and enforce engineering quality standards, procedures, and documentation.
• Implement and maintain a Quality Management System (QMS) specific to engineering.
• Conduct internal audits and drive CAPA processes to correct compliance gaps.
• Lead remediation projects to address deficiencies in design controls and regulatory compliance.

4. Cross-Functional Collaboration:

• Work closely with R&D, Manufacturing, and Quality teams to align engineering activities with organizational objectives.
• Provide strategic guidance on engineering quality and regulatory matters.

Qualifications:

• Bachelor's degree in Engineering or a related field (advanced degree preferred).
• 8+ years of experience in engineering quality and regulatory affairs, preferably in the medical device industry.
• In-depth knowledge of design controls, risk management, and verification/validation processes.
• Experience with CAPA, remediation projects, and internal audits.
• Strong understanding of FDA regulations, CE Marking, and ISO 13485.
• Problem-solving mindset with excellent cross-functional communication skills.

Compensation & Benefits:

• Salary: Competitive, based on experience.
• Benefits: Healthcare, dental, vision, 401(k) with match, paid time off, and professional development opportunities.

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