Regulatory + Quality Manager

Summary of Functions

The manager will serve as the Company’s Regulatory Representative and provide clients with regulatory services, strategy and process implementation that aligns with their products.

Responsible for developing, implementing, communicating, and maintaining the Company’s Quality Systems and Policies in compliance with ISO 9001:2015 and other applicable international quality system requirements. The manager will work with other personnel to train all company personnel in the requirements, documentation, and maintenance of the corporate quality system. The manager also works closely with the Design and Engineering departments to help guide their work in compliance with ISO 9001:2015 or in guidance with a client’s own QMS.

Major Duties and Responsibilities

Primary duties – 90%

  • Provide and manage regulatory services to clients
  • Provide leadership for developing and directing quality assurance and quality improvement initiatives for all products and services
  • Responsible for defining and implementing regulatory strategy including device classifications (both medical and non-medical) and a regulatory roadmap for clients
  • Design and implement QMS process for clients as a deliverable
  • Provide regulatory guidance to the company that aligns design and engineering with the client’s product vision
  • Maintain documentation related to all required quality system guidelines
  • Support new product development, continuous improvement and design cost reduction activities by integrating quality tools in the process
  • Establish and maintain a total quality management philosophy and promote philosophy throughout the company
  • Assist in designing testing procedures to fulfill Receiving Inspection and Final Inspection and Release activities
  • Interpret regulations, develop company policies and participate in overall planning
  • Monitors evolving domestic and international regulations and product specific standards

Secondary duties – 10%

  • Manage and maintain the company’s internal quality audit program and assess improvement initiatives resulting from all quality audits, internal and external
  • Manage and maintain the company’s vigilance and product complaint systems
  • Manage resources to develop and maintain the quality system
  • Provide training for department employees, and maintain their training records
  • Prepare and make presentations on quality assurance activities to upper management
  • Manage reported nonconformance and defects into the CAPA system
  • Serves as a contact with the certification bodies
  • Advise and train staff on the company Quality Management System and relevant ISO procedures

Core Competencies

Minimum Competencies

  • Ability to analyze data and present findings to management
  • Ability to communicate and consult with staff and registrars
  • Ability to control documents
  • Ability to organize and chair meetings
  • Excellent oral and written communications skills
  • Ability to interact effectively with top management team to develop and execute strategy
  • Ability to communicate and interact effectively with Design and Mechanical engineers as well as government agencies
  • Ability to think critically and to adjust to change
  • Ability to work independently, yet collaboratively
  • 5+ years of experience with Quality Systems design, implementation and Quality programs management
  • Working knowledge of ISO 9001, ISO-13485

Preferred Competencies

  • A related college or university degree
  • Working knowledge of ISO 9001:2015, Design Control, industry Electrical Safety Testing protocols

Organizational Relationships

  • This role works with the Partner & Strategy Leader and reports to them and the CEO

Show Us What You’ve Got!

If you think you could make an impact with us – please send us your resume along with a brief cover letter explaining why we’d be an awesome fit for each other. We look forward to hearing from you!

All qualified applicants will receive consideration for employment without regard to race, sex, age, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

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