Inogen, Inc.
  • RA/QA
  • Richardson, TX, USA
  • Full Time

ABOUT INOGEN Inogen was founded in 2001 to improve quality of life and increase freedom and independence for oxygen therapy users. Inogen is innovation in oxygen therapy. The Inogen mission is to improve freedom and independence for oxygen therapy patients through innovative products and services. Inogen is a manufacturer and Accredited Homecare Provider.

Inogen is focused on quality care, continuous improvement, and outstanding customer satisfaction. We are a stable, USA based company dedicated to providing an exciting and rewarding career to our employees. We completed a successful Initial Public Offering on the NASDAQ in 2014 and have demonstrated substantial growth over the last five years. Our work environment is casual yet high performing, and we are looking for seriously talented, motivated, and fast-paced professionals to join our team.

JOB DESCRIPTION 

The Regulatory Affairs Specialist has responsibility for ensuring organizational compliance with quality and regulatory standards for both product and company operations. The position is responsible for supporting the Quality Management System and for ensuring product design efforts are in step with business objectives and applicable government directives.

Key Competencies:

  • Assist in compiling, submitting, and monitoring reports and responses to regulatory authorities.
  • Support regulatory agency inspections and external audits.
  • Support Operations reporting and trending.
  • Support the Internal Audit Program as an internal auditor.
  • Support the Supplier Auditor Program as a supplier auditor, as required.
  • Provide support in company-wide Quality Management System training activities and provide regulatory expertise, as needed.
  • Support the Corrective and Preventive Action (CAPA) Program.
  • Support Kaizen initiatives to introduce improvements throughout the Quality Management System (QMS), as Regulatory Affairs department representative.
  • Participate in product development activities, including evaluating and advising personnel on regulatory impact throughout product lifecycle stages, ensuring that regulatory standards are understood, that a design control system is in place, that design validation activities are conducted, and that a Design History File (DHF) is maintained to support regulatory submissions.
  • Participate in transfer of approved product design to Manufacturing to meet market introduction and other key milestone target dates, ensuring that a Device Master Record is in place (specifications, bill of materials, drawings, material specifications, labeling, etc.).
  • Participate in the development of manufacturing and inspection/ test procedures, including required validations for final product release.
  • Participate in change control activities, such as design changes, manufacturing improvements, new supplier introductions, cost reduction initiatives, etc., ensuring that regulatory standards are understood.
  • Support the external standards management process by ensuring changes to standards and new standards introduced are understood and integrated into device design proactively.
  • Support post market surveillance (PMS) activities, including customer complaints/ adverse medical event reporting systems, clinical evaluation reports, etc.
  • Support key business relationships by providing regulatory expertise specific to contract manufacturing, private labeling arrangements, etc.
  • Assist in obtaining all necessary domestic and international regulatory registrations, product clearances/ approvals, certifications and in maintaining documentation needed to support ISO, FDA, and EU/ international compliance, allowing for the sale of Inogen products in US, EU, Canadian and other international markets, as determined by business objectives, as assigned.
  • Provide support to the Environmental Management System (ISO 14001).
  • Other duties as assigned.

Do you possess these abilities?

  • Knowledge of ISO 13485, ISO 14971 and FDA regulations required
  • Knowledge of DMEPOS accreditation requirements preferred
  • Experience with DMEPOS/ CMS preferred
  • Knowledge of ISO 14001 preferred
  • Experience in Regulatory Affairs and at least one (1) of the following: product development, manufacturing engineering, quality assurance, or production management required
  • Ability to support external/ internal audits required
  • Attention to detail and process improvement capabilities required
  • Excellent skills with database systems and Excel with capability to compile data from various sources to produce useful reports for trending and verifying process improvements required.
  • Familiarity with process improvement concepts (i.e. LEAN Six Sigma) preferred
  • ISO 13485:2016 Lead Auditor Certification and/or ASQ CQA, and/or ASQ CBA preferred

Requirements:

  • Operates at a task + project level for select projects which are specifically assigned to them
  • Able to execute tasks and project level work independently, able to sign off for Regulatory/QMS in some instances, as is deemed appropriate
  • Some supervision required
  • 3+ - 5 years of Regulatory experience within a medical device company
  • At least one (1) year of experience as a QMS internal auditor (may be concurrent with experience level noted above)
  • Will be able to mentor/train junior staff members
  • Bachelor's in a Technical Discipline Required

Work Conditions:

  • Office Environment

WHY INOGEN Inogen is a dynamic company that is not only focused on quality care of patients but is also committed to being a top employer.  Each of Inogen' s offices have a casual culture that supports employees being responsible and developing professionals.

We offer competitive salaries and a robust benefit package:

  • Employee Stock Purchase Plan 401 (K) plan available for all employees Health, dental, vision insurance Flexible spending accounts and wellness discount program Life Insurance Long Term Disability Robust paid time off and 8 paid holidays Employee Assistance Program

See the Inogen Team in action:

https://www.youtube.com/watch?v=dKoTMeJf5J4

 

Inogen Where we go to work hard to positively impact people's lives

 

Inogen is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. The EEO is the Law poster and its supplement are available here: http://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm; http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf.  The pay transparency policy is available here: http://www.dol.gov/ofccp/pdf/EO13665_PrescribedNondiscriminationPostingLanguage_JRFQA508c.pdf.

Inogen is committed to working with and providing reasonable accommodations to individuals with disabilities.  If you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to recruiting@inogen.net or call (972) 616-5668 and let us know the nature of your request and your contact information.

 

 

Inogen, Inc.
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