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Quality and Regulatory Specialist

Summary

The Quality and Regulatory Specialist C2Dx is a position with pathways to becoming a significant contributor to the Quality Assurance and Regulatory team. In this role, you will be a critical team member contributing to the execution of the company strategy for an evolving medical device company. This role will provide Quality Management System (QMS) and Product maintenance and improvements with significant time spent monitoring feedback and complaints, determining root cause and failure modes, performing data analysis, and trending, and executing changes for our customers and QMS. You will be expected to work alongside cross-functional teams and support our customers, products, services, and systems.

Key Responsibilities

  • Understand areas of responsibility according to the C2Dx QMS.
  • Execute quality and regulatory strategies to enhance profitability.
  • Primarily responsible for the development, maintenance, and improvement of the QMS processes in accordance with relevant regulatory requirements.
  • Research, organize, and draft business process maps, standard operating procedures (SOP), and work instructions (WI).
  • Work on cross-functional teams and collaborate with partners in the organization to document, clarify, and continually improve processes.
  • Help process owners and SMEs navigate the document management process and requirements.
  • Manage the preparation, review, and submission of pre-market submissions, design history file(s), technical file(s), and design dossiers, including establishing and maintaining necessary written procedures, such as for submission review, applications, CE marking and clearance (US and OUS compliance).
  • Serve as a quality and regulatory representative on new product development and sustaining engineering project teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for medical device file completion and regulatory submissions.
  • Correspond with regulatory agencies, and notified bodies, importers, and distributors as required by management for continued compliance with standards and regulatory requirements.
  • Responsible for reviewing and approving product and manufacturing changes for compliance with applicable standards and regulations, and developing and implementing QMS policies and procedures to ensure impact/risk assessment of all changes.
  • Drive a culture of safety and efficacy through quality tools such as 6S.
  • Support execution of internal/external audits, CAPA, nonconforming material, feedback and complaints, post-market surveillance, processes and procedures, and other duties as required by management.
  • Continually provide and contribute towards company and process improvements to the C2Dx QMS.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.

  • High school diploma, associate or bachelor’s degree preferred with 0-3+ years of relevant experience in similar roles.
  • Prior experience in a regulated environment desired
  • Prior experience managing projects and change management is preferred.

Working conditions

  • This is an hourly, non-exempt position that will require occasional evening work, and correspondence with customers, distributors, and regulatory bodies outside of normal working hours.
  • Travel not to exceed 20%
  • Must be eligible to work in the U.S. and provide proper documentation within 3 days of employment.
  • Must successfully pass a background screening and drug screening.

Physical requirements

  • A candidate may need to occasionally push, pull, or lift 25-50 lbs.
  • Frequent walking, standing, or sitting for extended periods of time.

About C2Dx 

C2Dx is a medical device company that acquires and invests in underserved products to propel their impact worldwide. Founded in early 2019 by medical device industry experts, C2Dx is committed to providing leading medical products and superior customer service while continually evolving to ensure that healthcare providers have the devices and technology they need.

At C2Dx, we offer a competitive salary, a comprehensive benefits package, and the chance to be a driving force in our organization’s growth.  Your experience will be valued, and your contributions will shape the future of the organization! If you are ready to lead, innovate, and inspire, apply today!

To Apply 

Please submit your resume to careers@c2dx.com.

C2Dx, Inc is an equal opportunity employer, which considers all applicants for employment without regard to race, color, religion, sex, national origin, age, disability, marital status, or any other characteristic protected by law. In addition, C2Dx also provides “reasonable accommodations” to qualified individuals with disabilities, in accordance with the Americans with Disabilities Act and applicable state and local laws.