Careers

As Contego Medical’s portfolio and geographical impact expands, so does our team. Contego’s mission is to improve the safety and ease of vascular procedures with the goal of positively impacting patient outcomes. We are a driven, passionate, experienced group of medical device professionals and we invite you to join our innovative team.

For more information on any of these positions, or to send your résumé for consideration, please email careers@contegomedical.com.

Position: Quality Systems Management Specialist
Department: Quality Assurance
Location: Raleigh, NC
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Position Requirements

Coordinates activities related to Contego’s Quality System. Assists in the creation and implementation of policies and procedures of Contego Medical’s Quality Management System. Requires working experience of quality systems, including, document and change control and understanding of corresponding regulatory requirements per FDA’s QSR and ISO 13485 regulations. It also requires the ability to work with various functions in the company to ensure compliance to document control and change control procedures as part of Contego’s Quality Management System. This position reports to the Vice President, Quality and Clinical Affairs.

Key Responsibilities

  • Maintain an effective Quality System
  • Plans, coordinates, and leads QA program associated with the creation and maintenance of GMP-related documents to ensure consistency with established standards
  • Maintains an effective document control system, including routing, review, organizing, filing, and maintaining QMS documents (SOPs, WIs, Forms, etc.) and records and ensures change control compliance with FDA’s QSR and ISO 13485
  • Manages company-wide training program including the coordination of training activities, review, filing, and monitoring company-wide training status.
  • Maintains external and internal audit schedule and Supplier Management Program
  • Manages CAPA process, support root cause analysis and implementation of corrective action
  • Assists in Complaint investigations
  • Other tasks as required or assigned by management

Qualifications

  • Minimum undergraduate degree in related field
  • 5+ years experience in Medical Device industry
  • Demonstrated understanding of ISO13485, ISO14971, and 21CFR820
  • Well-developed teamwork and collaboration skills and the ability to communicate clearly and professionally both verbally and in writing.
  • Ability to analyze, understand and effectively communicate QSR/QMS material and scientific/technical writing.
  • Must have prior experience in document control in a regulated work environment.
  • Ability to organize and set priorities in a fast-paced environment and work independently with minimal supervision.

The job responsibilities above are not comprehensive or exhaustive. The Company reserves the right to adjust, add to or eliminate any aspect of the above description. The Company also retains the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.

Position: Director, Regulatory Affairs
Department: Regulatory Affairs
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Position Requirements: Responsible for implementing the regulatory strategies that will allow the company to market its products worldwide through the preparation of global regulatory submissions.

Key Responsibilities:

  • Develop and implement regulatory strategies and processes to support global commercialization of the company’s products including product registrations, investigational device exemptions, 510(k) submissions, international notifications and pre-market approvals.
  • Support notified body audits and/or FDA inspections.

Qualifications:

  • Bachelor’s degree in biology or a related field of study.
  • 10 years of relevant experience in regulatory affairs in the medical device industry.
  • Cardiovascular device experience mandatory.
  • Class II and III vascular medical device experience is strongly preferred.
  • Experience with device submissions, technical files, design dossiers, 510(k)s, PMAs and interaction with regulatory bodies.
  • Strong written and verbal communication skills.