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 acquisitions, etc. * Ensure regulatory standards are understood, and maintain the organizations design control system is in place. * Support Lean and Kaizen initiatives. * Support Operations reporting and trending. * Comply with all company policies and procedures. * Assist with any other duties as assigned.

Knowledge, Skills, and Abilities * Knowledge of ISO, EU MDR, US FDA and global medical device regulations. * Knowledge of DMEPOS accreditation requirements. * Experience with DMEPOS/ CMS. * Ability to facilitate external/ internal audits required. * Attention to detail and process improvement understanding required. * Excellent skills with database systems and Excel with capability to compile data from various sources to produce useful reports for trending and verification required.

* Familarity with process improvement concepts (i.e., LEAN Six Sigma).

* Capable of compiling data from various sources to produce useful reports and capable of trending and verifying process improvements. * Excellent management skills, both of individuals as well as projects. * Excellent oral and written communication skills are required. * Must demonstrate effective conflict resolution. * Analytical and problem-solving skills and ability to multitask are required. * Excellent planning, communication and organizational skills are required. * Ability to effectively interface with different departments within the company is required.

Qualifications(Experience and Education) * Bachelor’s Degree in a technical discipline required. * MBA or advanced degree in management or professional certification in manufacturing disciplines, preferred. * 12-15 years of medical device Regulatory Affairs experience required.Experience in medical device Regulatory Affairs and at least one (1) of the following: product development, manufacturing engineering, or production management required. Regulatory international experience, preferred. * 6 years management experience, with a minimum of five direct reports, required. * Advanced knowledge of/ proficiency in Microsoft Office required. * Advanced knowledge of ISO 13485 and ISO 14971 required. * ISO 13485 (current edition) Lead Auditor Certification, preferred. * RAC preferred. * Advanced knowledge of 21 CFR 820 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.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.