The Senior Regulatory Affairs (RA) Specialist has responsibility for ensuring organizational compliance with quality and regulatory standards for both product and company operations. The position is responsible for obtaining regulatory clearances/ approvals and overseeing a Quality Management System (QMS) that is in keeping with business objectives and government directives.
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.
Compile, submit, and monitor reports and responses to regulatory authorities and related third-parties.
Support regulatory agency and third-party inspections and audits.
Maintain/ support the Internal Audit Program company-wide for a fully compliant Quality Management System (QMS) - including within its scope applicable accreditation and Home Medical Equipment (HME)/ Durable Medical Equipment (DME) compliance provisions.
Support the Supplier Auditor Program as a QMS Supplier Auditor, as required.
Provide company-wide Quality Management System (QMS) training and regulatory expertise, as needed.
Support the Corrective and Preventive Action (CAPA) program.
Participate in product development activities, including evaluating and advising personnel on regulatory impact throughout product lifecycle stages, ensuring that regulatory-specific (product and process) 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.
Support Engineering efforts with review of technical/ regulatory standards for impact to development/ product.
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 (DMR) 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 key business relationships by providing regulatory expertise specific to contract manufacturing and/or private label arrangements.
Manage post market surveillance (PMS) activities, including customer complaints/ adverse medical event reporting systems, risk files, etc.
Assist with the compilation of Clinical Evidence Reports, as needed.
Facilitate Kaizen initiatives to introduce improvements throughout the Quality Management System and/or serve as the Regulatory Affairs delegate for such forums, as needed.
Support Operations reporting and trending.
Mentor junior staff and manage consultants, as assigned.
Do you possess these abilities?
Knowledge of ISO and FDA regulations required
Previous experience in Regulatory Affairs (specifically medical devices) and at least one (1) of the following: product development, manufacturing engineering, quality assurance, or production management required
Ability to facilitate external/ internal audits required
Attention to detail 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.
Knowledge of DMEPOS accreditation requirements preferred
Experience with DMEPOS/ CMS preferred
Familiarity with process improvement concepts (i.e. LEAN, Six Sigma, etc) preferred
ISO 13485:2016 Lead Auditor Certification and/or ASQ CQA, and/or ASQ CBA preferred
BS in Engineering, Biological Science or other technical discipline or equivalent
Five (5) years minimum experience in medical device manufacturing environment
Telecommuting is allowed.
Additional Salary Information: 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
Internal Number: 56135
About Inogen, Inc.
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.