Job Description

Job Summary

This is a hybrid position at Inogen facilities located in Plano, TX or Beverly, MA.

Responsible for the development and execution of regulatory strategy for Inogen products. The Director of Regulatory Affairs will lead a team and activities resulting in obtaining and maintaining regulatory approval in support of Inogen business objectives and applicable global medical device regulations.

The position plays a critical role in supporting Inogen’s ambitious global growth objectives and will work closely with internal stakeholders such as R&D, Clinical, Commercial, Operations, and Quality, as well as external stakeholders such as FDA, Notified Bodies, etc.

Responsibilities:

• Serve as regulatory subject matter expert providing timely, clear, and consistent regulatory guidance for Inogen products throughout their entire lifecycle
• Prepare and obtain approval for product submissions to FDA and other global regulators
• Ensure compliance with all applicable regulatory requirements
• Maintain site registrations, regulatory files, and records
• Provide regulatory support for Inogen cross-functional regulated activities such as design, manufacturing, clinical trials, audits, post-market surveillance, etc.
• Review and approve product design, labeling, manufacturing, and quality assurance changes, as well as marketing advertising and promotional materials to ensure compliance with internal procedures, applicable regulations and guidelines
• Monitor regulatory trends, regulations, and guidance to inform regulatory strategies and ensure ongoing compliance with changing regulatory requirements
• Lead, mentor, and develop a high-performing team of regulatory professionals, fostering a culture of excellence, collaboration, and continuous improvement
• Build and maintain productive relationships with global regulatory authorities and external stakeholders, consultants, regulatory agencies, and industry groups
• Performs other duties as required

Knowledge, Skills, and Abilities:

• Demonstrated proficiency and knowledge of current medical device Good Manufacturing Practices, FDA 510(k), EU MDR, FDA Advertising and Promotion guidance, and other global medical device regulations
• Exceptional leadership and team-building skills, with the ability to work highly effectively in cross-functional teams in a dynamic and fast-paced environment
• Analytical mindset, highly organized, detail oriented, and ability to prioritize
• 10 - 15% domestic and international travel required
• Must have exceptional written, verbal, and interpersonal skills with internal and external stakeholders

Qualifications: (Education and Experience)

• Bachelor’s degree in engineering, Life Sciences, or technical discipline is required
• Applicable advanced degree preferred
• RAPS Certification (RAC) preferred
• Minimum of 8 years of Regulatory Affairs experience focusing on submissions and global market access within the medical device industry
• Minimum of 5 years of people management experience
• Minimum of 3 years working for a global medical device manufacturer with a minimum of $500m USD annual revenue
• Medical device FDA and EU submissions resulting in product approval
• Experience in medical device approvals beyond in geographies such as Asia, Latin America, South America, Australia, etc.
• Demonstrated success in leading a team of regulatory professionals in a fast-paced, global environment

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.

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