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QA/RA Manager

Job Description

The QA/RA Manager will serve as an experienced project manager supporting the Regulatory and Quality team. This role will ensure regulatory strategies are clearly delineated, supported, and implemented in the development, commercialization, and life cycle management of the business. The position oversees the preparation and submission of domestic 510(k)s, and international regulatory filings for the organization.

Summary

C2Dx is a medical device company based in Kalamazoo, Michigan, that invests in and refines the delivery of valuable, niche products to propel their growth and accessibility worldwide. Founded in early 2019 by 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.

Key Responsibilities

  • Define and execute the RA/QA activities to support business unit and corporate strategy; a. product listing/classification recommendations b. maintain current knowledge on regulatory requirements
  • Will be identified as Management Representative for C2Dx
  • Provide straightforward guidance on document requirements to internal functional departments prior to and during product development to ensure predictable regulatory filing dates and approvals
  • Provide counsel, training, and interpretation of the FDA and other regulatory authorities’ feedback, policies, and guidelines
  • Establish, manage, and maintain compliance with FDA QSR, including the establishment of registration, Quality Assurance including, but not limited to, Product Release, CAPA, NCR, Complaints, Supplier Qualification, Document Control, Training, Internal/External Audits; Oversee preparation and filing of all regulatory documents with the FDA and international regulatory agencies
  • Manage regulatory activities which include coordinating product changes, regulatory requirements, and submission schedules to assure timely regulatory approvals by effectively working with: a. internal functional departments and Legal external parties including regulatory bodies such as notified bodies and FDA, third-party test laboratories, distributors and consultants
  • In accordance with the C2Dx Quality Management System, as a member of the executive team, responsible for defining the Company’s Quality Objectives and initiating Management Review
  • Perform other duties as assigned:
    • Participate in external and internal audits. Act as a cross-functional team member within the quality system.
    • Manage Warehouse and distribution departments to ensure customer delivery
    • Help monitor, maintain, and improve the quality system.

Qualifications and Skills

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.

  • Bachelor’s degree or equivalent/graduate degree preferred with 7 – 12+ years of relevant experience in similar roles in a regulated environment.
  • Minimum 3 years responsible for direct reports
  • Prior experience managing projects and change management is preferred.
  • Ability to learn and understand technical terms and medical information.
  • Ability to communicate this information verbally and in a presentation environment
  • Ability to present very technical information professionally to others.
  • Excellent analytical and interpersonal skills
  • Demonstrated effective organizational skills, and ability to manage multiple priorities with varying deadlines
  • Computer skills (Microsoft Office); experience in Salesforce preferred.
  • Excellent verbal and written communication skills. Professional presence.

Job Requirements

  • Up to 25% travel required
  • Ability to push, pull or lift at least 25 pounds
  • Frequent walking, standing or sitting for extended periods of time
  • Must have a valid driver’s license
  • 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, excluding THC

Work Environment

The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

  • This is a salaried exempt position that will require occasional evening work, and correspondence with customers, distributors, and regulatory bodies outside of normal working hours.
  • Office environment
  • Manufacturing environment

To Apply 

Please submit your resume to careers@c2dx.com