Regulatory Affairs and Quality Assurance Director
Company: Inogen Inc
Posted on: October 15, 2020
REGULATORY AFFAIRS AND QUALITY ASSURANCE DIRECTOR
Richardson, TX, USA Req #166
Tuesday, September 29, 2020
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.
The Regulatory Affairs and Quality Assurance Director is
responsible for regulatory compliance and quality assurance
programs of Inogen. This position ensures global product and
operational compliance related to Class-2 (and accessory) medical
device design, manufacture and sales; obtaining regulatory
approvals; and establishing and maintaining quality and
environmental management systems in keeping with business
objectives. The Regulatory Affairs and Quality Assurance Director
oversees regulatory inspections and ensures the timely filing of
documents, records and reports with various regulatory agencies.
Manage quality assurance and regulatory affairs activities per
approved budget and annual operating plan
Responsibilities (Specific tasks, duties, essential functions of
Obtain and manage all necessary domestic and international
regulatory registrations, product clearances/ approvals,
certifications or other documents required to maintain ISO
13485-2016, MDSAP and FDA registration to facilitate the sale of
Inogen products in US, State of California, European, Canadian,
China and other international markets as determined by business
Maintain documentation needed to support FDA, ISO and EU/
international compliance, allowing for the sale of Inogen products
in US, EU, Canadian and other international markets, as determined
by business objectives.
Compile, submit, and monitor reports and responses to regulatory
Assist with coordinating inspections of Inogen, its subsidiaries,
and contract manufacturers.
Design, implement, and maintain an Internal Audit Program
company-wide for a fully compliant Quality Management System (QMS)
- including within its scope applicable accreditation and Home
Medical Equipment (HME) for Durable Medical Equipment (HME)
compliance provisions - and Environmental Management System (EMS).
Grow program and provide support as additional sites/ operations
are added subject to Inogen's QMS.
Lead and conduct or support second-party supplier audits, as
Manage post market surveillance (PMS) and vigilance activities,
including customer complaints analysis/adverse medical event
reporting systems, clinical reports, etc. and verify actions taken
to improve product quality are appropriately effective.
Track and tend internal quality to report on production yields,
complaint trends, production rates and service costs. In order to
show continuous improvement, so continued improvement in products
can be achieved.
Provides guidance on information infrastructure including hardware
and software verification and validation requirements to support
performance and quality improvement systems.
Managing the Corrective and Preventive Action (CAPA) system.
Manage the quality assurance function reviewing both internal and
external quality of Inogen products. Establish and maintain
supplier quality audits, supplier monitoring, standards for
verification of received product, and supplier corrective
Participate in product development activities, including evaluating
and advising personnel on regulatory impact through product
Ensure regulatory standards are understood, and maintain the
organizations design control system is in place.
Implement system to capture design validation activities are
conducted, and that a Design History File (DHF) is maintained to
support regulatory submissions.
Direct incoming inspection activities for any raw material or
components of Inogen.
Participate in the 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, labelling, etc.).
Participate in the development of manufacturing and inspection/
test procedures, including required validations for final product
Participate in risk management activities and in the development of
risk files for company products to ensure compliance with standards
and that output is incorporated into product design.
Participate in change control activities, such as design changes,
manufacturing improvements, new supplier introductions, cost
reduction initiatives, etc., ensuring that regulatory standards are
Provide mentorship to other Inogen employees and/or Regulatory
Affairs staff, as appropriate.
Support key business relationships by providing regulatory
expertise specific to contract manufacturing, private label
arrangements, due diligence for possible acquisitions, etc.
Provide company-wide Quality Management System (QMS)and
Environmental Management System (EMS) training and regulatory
expertise, as needed.
Support Lean and Kaizen initiatives to introduce improvements
throughout the quality management system.
Support Operations reporting and trending.
Maintain regular and punctual attendance.
Comply with all company policies and procedures.
Assist with any other duties as assigned.
Knowledge, Skills, and Abilities
Capable of compiling data from various sources to produce useful
reports and capable of trending and verifying process
Excellent management skills, both of individuals as well as
Must have strong work ethic.
Excellent oral and written communication skills required.
Attention to detail is required.
Effective conflict resolution.
Analytical & problem-solving skills & ability to multi task.
Solutions-oriented problem solver.
Excellent planning, communication and organizational skills.
Ability to effectively interface with different departments within
In-depth knowledge of FDA , ISO 13485, CMS and MDSAP programs and a
track record of successfully implementing and maintaining these
Strong project management and organizational skills. Ability to
systematically monitor, detect and improve regulatory, quality and
Business acumen able translate business strategy and objectives
into a regulatory/compliance program. Able to show flexibility in
approach depending on the business need.
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:
The pay transparency policy is available here:
Keywords: Inogen Inc, Richardson , Regulatory Affairs and Quality Assurance Director, Executive , Richardson, Texas
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