Inogen, Inc.
  • RA/QA
  • Cleveland, OH, 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 International Regulatory Affairs (RA) Specialist has responsibility for gaining and sustaining market access to countries of choice for product distribution. The position will obtain regulatory clearances/ approvals based on company objectives, as well as partner with Engineering and other members of the Regulatory team to ensure country-specific requirements are understood and integrated throughout design control and post-product launch activities.

Key Competencies:

  • Obtain and manage all necessary domestic and international regulatory registrations, product clearances/ approvals, certifications.
  • Work directly with distributors and in-country consultants, as applicable, to fulfill regulatory requirements for product registration and/or product reimbursement.
  • Generate and maintain documentation needed to support international registration, ongoing compliance, and/or product reimbursement, allowing for the sale of Inogen products in markets identified by Sales and Marketing/ as determined by business objectives.
  • Prepare submissions and monitor reports and responses to regulatory authorities, ensuring timely and comprehensive follow-up.
  • Advise personnel on regulatory impact throughout product lifecycle stages, ensuring that international regulatory requirements for registration and reimbursement are understood and those that apply are adopted to support product clearance to market.
  • Monitor countries in which Inogen product is distributed for regulatory changes and revise processes and/or documentation to ensure uninterrupted access, partnering with internal and/or external resources, as needed.
  • Support regulatory agency inspections and audits for all subject sites.
  • Support Operations reporting and trending.

Do you possess these abilities?

  • Knowledge of ISO, MDD/ MDR, and FDA regulations required
  • Knowledge of regulatory and reimbursement challenges specific to Europe, Middle East, and Africa (EMEA) required
  • Knowledge of DMEPOS accreditation requirements preferred
  • Willingness to travel (infrequently) to meet distributors and/or direct customers required
  • Fluency in foreign language preferred
  • Attention to detail required

 

Requirements:

  • Operates at a task level
  • Limited cross-functional responsibilities, able to sign off for Regulatory in limited instances, as is deemed appropriate
  • Substantial supervision required
  • 2-3 years of experience within medical device industry
  • 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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