Regulatory Affairs Specialist, IV

Inogen

4d • $106,000 - $127,000

About The Position

The Regulatory Affairs position ensures compliance with global medical device regulations throughout the product lifecycle (Class 2 medical devices, electromechanical devices, patient contact devices, Software as a medical device, as well as digital health related devices).
This role involves developing and executing regulatory strategies, preparing and submitting documentation to regulatory authorities, and maintaining adherence to standards such as FDA, EU MDR, and ISO 13485.
The position requires collaboration with cross-functional teams to support product development, labeling, marketing, and post-market activities, while monitoring regulatory changes and ensuring timely implementation of projects.

Requirements

• Bachelor’s Degree in a technical discipline required.
• At least 8 years of medical device Regulatory Affairs experience.
• Demonstrated 510K and EU MDR submission experience as an Regulatory Affairs lead.
• Experience in software as a medical device and digital health required; 1 year of QMS internal auditing experience required.
• Intermediate knowledge of/ proficiency in Microsoft Office required.
• ISO 13485 (current edition) Lead Auditor Certification and/or ASQ CQA and/or ASQ CBA preferred.
• Advanced knowledge of ISO 13485 required
• Advanced knowledge of ISO 14971 required
• A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills and abilities.
• Knowledge of ISO, EU MDR and FDA regulations.
• 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 Sigma).
• Must have strong work ethic.
• Excellent oral and written communication skills are required.
• Attention to detail is required.
• Must demonstrate effective conflict resolution.
• Analytical and problem-solving skills and ability to multitask are required.
• Must be solutions-oriented problem solver.
• Strong project management and leadership skills
• Excellent planning, communication and organizational skills are required.
• Ability to effectively interface with different departments within the company is required.

Nice To Haves

• ISO 13485 (current edition) Lead Auditor Certification and/or ASQ CQA and/or ASQ CBA preferred.

Responsibilities

• Sign off for Regulatory.
• Lead work of other Regulatory Affairs team members.
• Lead the process of 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.
• Lead regulatory agency inspections and audits.

Benefits

• In addition to the expected base salary, this role is eligible to participate in Inogen’s annual performance bonus incentive plan, highly competitive and company-sponsored benefits, and wellbeing programs rooted in our strong culture of excellence. As a valued member of our team, Inogen provides health, dental, and vision insurance, 401(k) plan plus employer contribution and match, and generous paid leaves such as vacation and sick leave, including paid volunteer time, that can support you and your family through moments that matter.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level