Director of Regulatory Affairs

Job Summary:

The Director Regulatory Affairs is responsible for Inogen product and operational compliance related to medical device design, manufacture, and sales; maintaining compliance to regulatory approvals; and establishing and maintaining the post-market surveillance system in keeping with business objectives.

Responsibilities(Specific tasks, duties, essential functions of the job)


* Manage compliance to all domestic and international regulatory registrations, product clearances/ approvals, certifications.


* Manage interactions with US FDA, including regulatory filings, meetings, registrations and listings.


* 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 authorities.


* Manage and oversee product labeling.


* Manage and oversee the Regulatory Intelligence platform (RegDesk) for product registration guidance, completion and tracking of regulatory approvals.


* Assist with coordinating inspections of Inogen, its subsidiaries, and contract manufacturers.


* Manage post market surveillance (PMS) and vigilance activities, including customer complaints/ adverse medical event reporting systems, clinical reports, etc.



* Identify, manage and obtain relevant external standards and ensure changes to standards and new standards introduced are understood and integrated into device design.


* Participate/manage and oversee Regulatory participation 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 development of manufacturing and inspection/ test procedures, including required validations for final product release.


* Co-Lead risk management activities with Quality and Medical Affairs functions and ensure 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 understood.



* Manage assigned staff and consultants in the day-today performance of their jobs.

For direct reports, complete performance appraisals and identify and cultivate opportunities for their growth and development.



* Support key business relationships by providing regulatory expertise specific to contract manufacturing, private label arrangements, due diligence for possible acquisi...