HoverTech International, a medical device company and leader in the safe patient and handling  and movement is seeking a Director of Quality Assurance & Regulatory Affairs to join their team. This opportunity is in Allentown, PA, has one direct report and requires 10% international travel.

The Director of Quality Assurance & Regulatory Affairs will lead the company’s quality system and regulatory compliance activities. This role is responsible for ensuring that the Quality Management System meets FDA, ISO 13485, and global regulatory requirements, while also serving as the company’s primary regulatory contact for the U.S., Canada, U.K., and EU.

The ideal Director of Quality Assurance & Regulatory Affairs candidate has solid experience with Class II devices, understands global regulatory frameworks, and is comfortable in a hands-on leadership role in a growing organization.



HoverTech International offers…

• Competitive compensation
• 100% employer paid benefits (for employee and family)
• Medical, dental, vision
• 401K plan
• Life insurance
• Tuition reimbursement
• Laid-back dress code and is dog friendly! 

The Director of Quality Assurance & Regulatory Affairs will be responsible for:

Quality Assurance (QA)

• Maintain and continually improve the Quality Management System in compliance with FDA 21 CFR 820, ISO 13485, and applicable global standards.
• Oversee CAPA, complaint handling, non-conformances, internal audits, and supplier quality.
• Serve as the Supplier Quality Contact, managing supplier evaluations, audits, and ongoing performance monitoring.
• Lead document control, change control, training systems, and production quality processes.
• Oversee risk management activities in accordance with ISO 14971.
• Serve as the Management Representative during audits and inspections.

Regulatory Affairs (RA)

• No 510(k) submissions required, but responsible for all ongoing global regulatory maintenance.
• Serve as the company's: FDA Registration Owner and primary FDA contact, US Agent for applicable products, EU PRRC (Person Responsible for Regulatory Compliance) for EUDAMED, Canada Regulatory Contact (e.g., MDEL maintenance) and UK Responsible Person / PRRC.
• Maintain device listings, establishment registrations, and regulatory documentation for all markets.
• Coordinate with distributors, authorized representatives, and regulatory bodies.
• Review and approve labeling, IFUs, marketing content, and product changes for regulatory compliance.
• Monitor regulatory changes and communicate impacts to leadership.

Leadership

• Work closely with Engineering, Operations, and Executive Leadership to embed quality and regulatory requirements across the organization.
• Provide clear, practical regulatory guidance for sustaining products and new initiatives.
• Represent QA/RA during leadership meetings, audits, and customer visits.

Director of Quality Assurance & Regulatory Affairs Qualifications:

• Bachelor’s degree in engineering, science, quality, regulatory, or related field.
• 5–10+ years of regulatory and quality experience in medical devices.
• 5+ year’s experience with a QMS (Greenlight Guru preferred).
• Strong understanding of Class I/ Class Il medical device requirements.
• Experience with FDA QSR, ISO 13485, and global regulatory frameworks.
• Experience managing establishment registrations and serving as a regulatory contact.
• Background in supplier quality, audits, and QMS compliance.
• Excellent organizational, documentation, and communication skills.
• Must be open to 10% international travel.