Regulatory Affairs Specialist II
Company: Inogen, Inc
Posted on: May 3, 2021
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 position is responsible for 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
Responsibilities (Specific tasks, duties, essential functions of
- Participate in product development activities, including
evaluating and advising personnel on regulatory impact through
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 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 change control activities, such as design
changes, manufacturing improvements, new supplier introductions,
cost reduction initiatives, etc., ensuring that regulatory
standards are understood.
- Assist in obtaining regulatory registrations, product
clearances/ approvals, certifications and with maintaining
documentation needed to support ISO, FDA, and other regulatory
compliance, allowing for the sale of Inogen products.
- Support key business relationships by providing regulatory
expertise specific to contract manufacturing, private label
arrangements, due diligence for possible acquisitions, etc.
- Assist in compiling, submitting, and monitoring reports and
responses to regulatory authorities.
- Support regulatory agency inspections and audits.
- Participate in the Internal Audit Program as an internal
- Support the Supplier Audit Program as an auditor.
- Support the Corrective and Preventive Action (CAPA)
- Support post market surveillance (PMS) activities, including
customer complaint handling and regulatory analysis efforts to
- Support the external standards management process by ensuring
changes to standards and new standards introduced are understood
and integrated into device design proactively.
- Participate in company-wide quality management system training
and provide Regulatory expertise.
- Support Lean and Kaizen initiatives to introduce improvements
throughout the quality management system.
- Support Operations reporting and trending.
- Limited sign off for Regulatory.
- Lead Corrective and Preventive Action (CAPA) program
- Lead international product registration efforts.
- Maintain regular and punctual attendance.
- Comply with all company policies and procedures.
- Assist with any other duties as assigned.
Knowledge, Skills, and Abilities
- Knowledge of ISO, MDD/ MDR and FDA regulations.
- Knowledge of DMEPOS accreditation requirements.
- Knowledge of DMEPOS accreditation requirements.
- Experience with DMEPOS/ CMS.
- Experience in medical device Regulatory Affairs and at least
one (1) of the following: product development, manufacturing
engineering, quality assurance, or production management.
- Ability to support external/ internal audits.
- Attention to detail and process improvement capabilities.
- 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.
- Familiarity with process improvement concepts (i.e., LEAN Six
- Must have strong work ethic.
- Excellent oral and written communication skills are
- Attention to detail is required.
- Must demonstrate effective conflict resolution.
- Analytical and problem-solving skills and ability to multitask
- Must be solutions-oriented problem solver.
- Excellent planning, communication and organizational skills are
- Ability to effectively interface with different departments
within the company is required.
Qualifications (Experience and Education)
- Bachelor's Degree in a technical discipline required.
- 2-5 years of medical device Regulatory Affairs experience
required; 1 year of QMS internal auditing experience required.
- Intermediate knowledge of/ proficiency in Microsoft Office
- ISO 13485 (current edition) Lead Auditor Certification and/or
ASQ CQA and/or ASQ CBA preferred.
- Intermediate knowledge of ISO 13485 preferred.
- Intermediate knowledge of ISO 14971 preferred.
- A combination of training, education and experience that is
equivalent to the qualifications listed above and that provides the
required knowledge, skills, and abilities.
We thank all applicants in advance for their interest in the
position. However, only those selected for an interview will be
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;
The pay transparency policy is available here:
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
firstname.lastname@example.org or call (972) 616-5668 and let us know the
nature of your request and your contact information.
- Job Family Regulatory Affairs Specialist
- Job Function Individual Contributor
- Pay Type Salary
- Required Education Bachelor's Degree
- Inogen, Inc., 600 Shiloh Road, Plano, Texas, United States of
Keywords: Inogen, Inc, Plano , Regulatory Affairs Specialist II, Other , Plano, Texas
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