Regulatory & Quality Consultant – Medical Device

Consulting Position Long-term

Position Overview: The RA/QA Consultant is responsible for all activities involving quality assurance and compliance within the Company’s quality management system and domestic and international regulatory requirements. The consultant will oversee all quality activities while providing strategic direction and tactical execution. The consultant will maintain quality systems and processes, including developing design control, training, risk management, document control, and maintenance of the Device Master File.

Responsibilities:

• Lead design control implementation and adoption through preclinical and clinical activities.
• Develop and execute US Regulatory Strategies for product development and submissions.
• Act as a liaison between the Company and FDA, respond to inquiries and requests for information.
• Lead the planning and implementation of risk management efforts.
• Lead the development and execution of vendor selection, specification drawings, quality agreements, and verification and validation protocols.
• Experience with the creation of V&V protocols and test reports.
• Ensure that the Quality Management System is established, implemented, and maintains its effectiveness in accordance with applicable standards.
• Maintain and review documentation for quality and regulatory impact as required by regulatory agencies and internal customers.
• Develop and implement effective training programs to achieve and maintain quality system and regulation awareness, ISO certifications, and compliance.
• Establish key quality metrics and annual quality goals; prepare trending reports for the quarterly management review meetings.
• Develop post-market and internal assessment processes for the organization, including CAPA, complaint handling, and field action.

Qualifications:

• Experience with 510(k) submissions and PMA applications is required.
• Undergraduate degree in engineering or a scientific or technical discipline is required.
• 7+ years of quality & regulatory medical device experience industry experience required.
• Experience in the development, implementation, maintenance, and ongoing support of the Quality Management System, including document creation and revision to SOPs, forms, and work instructions.
• Demonstrated proficiency with quality system procedures and medical device directives, including 21 CFR 820 and related international standards.
• Experience interacting with the FDA, Notified Bodies, and other regulatory agencies.
• Class III Premarket Approval (PMA).
• Ability to work effectively in a team environment and on cross-functional teams.

#medicaldevice #510(k) #PMA #QMS #designcontrol #qualityassurance #consulting #contractor #capa #contracting #regulatoryaffairs