The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Ensure D. A. Surgical is compliant with applicable global regulatory requirements, and that regulatory requirements are properly translated into company procedures and practice.
Expansion and implementation of Quality Management Systems for D. A. Surgical (a Class I
Medical Device company). Responsible for all quality systems within the company and enforcement of quality system requirements for suppliers/vendors. Prepares trending reports for quality process execution for the company (both internal and external sources). Responsible for non-conformance resolutions (product and process) and CAPA executions. Directs, through management team and staff, compliance to Quality Management System and Medical Device Regulations.
Essential Duties and Responsibilities
• Act as the direct interface with domestic and international regulatory agencies.
• Develop, implement, and maintain Quality Management System in compliance with US and international medical device quality system regulations (e.g., 21 CFR 820, ISO 13485,
• Generate and manage international and domestic regulatory submissions, registrations, authorizations and certifications.
• Responsible for all audits and inspections.
• Work with international distributors and vendors for regulatory documentation, needs and strategies.
• Maintain all regulatory files required by regulating agencies.
• Define and direct quality improvement programs (product, process, and systems).
• Identification and prioritization of improvement opportunities.
• Define the objectives, requirements, and assumptions necessary to complete the prioritization process and gain agreement from stakeholders.
• Establish the metrics for as well as monitors the effectiveness of quality system compliance.
• Leverage team capabilities from across functions and external relationships to support business objectives.
• Must possess strong ability to negotiate and maximize effectiveness of resources and influence others internally and externally.
• 7+ years international medical device regulatory experience
• 12+ years of relevant medical device quality experience, including cross-functional teams, resource/budget management and experience in management of Supplier and manufacturing controls.
• Must possess strong knowledge of quality system principles (e.g., non-conformances and complaint handling, CAPA, risk management, supplier controls, manufacturing controls, both internal and external reporting requirements) and solid knowledge of related disciplines (e.g.,
• Proven track record of management/leadership effectiveness, with strong collaboration skills.
• Experience in international Regulatory Submissions and communicating with International Regulatory agencies.
• Results focused.
• Exceptional communications skills, both written and oral.
• Statistical controls (testing requirements, verification and validation plans).
• Six Sigma or LEAN experience is desirable.
Internal Number: Quality & Regulatory Dire
About D.A. Surgical
Passion for Patient Safety in the Surgical Suite™
D. A. Surgical provides reusable and single-use surgical table accessories focused on patient, staff, and equipment safety.
TrenGuard® is the company’s flagship product. It is a standard of care positioning device for patients being placed in the Trendelenburg position.
ArmGuard® provides has an application in any surgical procedure utilizing the supine position.
FaceGuard® acts as both a patient face protection device and a versatile table mounted instrument tray.
ShroudGuard® protects surgical table pedestal shrouding from accessory clashing damage.
D. A. Surgical devices have application for usage during conventional and robotic assisted laparoscopy and open surgery for specialties including Urology, GYN, General and ColoRectal.
Founder, Dan Allen, invented the boot-style surgical stirrups design which is found in nearly every OR.
A respected pioneer and product designer who has dedicated more than 40 years to the study of anatomy and physiology as they relate to the proper positioning of patients in surgery.
Participated in over 3,000 surgeries observing patient safety and positioning issues, which motivated him to develop products to address unmet needs.