Regulatory Affairs Specialist, IV

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.

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

Regulatory Affairs Level I

• Participate 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 followed, that design validation activities are conducted, and that a Design History File (DHF) is maintained to support regulatory submissions.

• Participate in change control activities, such as design changes, manufacturing improvements, etc., ensuring that regulatory standards are understood and product registrations are updated accordingly where necessary.

• Assist in obtaining product 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.

• Support product registration activities by providing regulatory expertise specific to software development and product labeling.

• Assist in compiling, submitting, and monitoring reports and responses to regulatory authorities.
• Support regulatory agency inspections and audits.
• Support the external standards management process by ensuring changes to standards and new standards introduced are understood and integrated into device design proactively.
• Participate in company-wide quality management system training and provide Regulatory expertise.
• Represent RA function on weekly core team meetings for R&D, sustaining, manufacturing and geo expansion.
• Maintain regular and punctual attendance.
• Comply with all company policies and procedures.
• Assist with any other duties as assigned.

Regulatory Affairs Level II (Regulatory Affairs Specialist)

In addition to items listed for Regulatory Affairs Level I (Regulatory Affairs Associate), Regulatory Affairs Level II (Regulatory Affairs Specialist) may also be responsible for the following:

• Limited sign off for Regulatory.
• Lead international product registration efforts.
• Assist in preparing and updating regulatory procedures, technical files, and submissions for domestic and select international markets (e.g., FDA, CE‑marking)
• Conduct regulatory research and compile regulatory intelligence on new or amended regulations
• Support review of labeling and promotional materials for compliance

Regulatory Affairs Level III (Senior Regulatory Affairs Specialist)

In addition to items listed for Regulatory Affairs Level II (Regulatory Affairs Specialist), Regulatory Affairs Level III (Senior Regulatory Affairs Specialist) may also be responsible for the following:

• Develop and implement regulatory strategies for product lifecycle activities
• Prepare, compile, and manage submissions (e.g., 510(k), EU Technical Files)
• Liaise with regulatory authorities and respond to queries
• Oversee labeling and promotional reviews;
• Support post-market activities (complaints, CAPA)
• Provide regulatory guidance across R&D, Quality, Marketing, and Manufacturing
• Sign off for Regulatory.
• Provide high level of technical expertise to relevant job functions.
• Assist with regulatory agency inspections and audits.
• Support Lean and Kaizen initiatives to introduce improvements throughout the quality management system.

Regulatory Affairs Level IV (Regulatory Affairs Principal)

In addition to items listed for Regulatory Affairs Level III (Senior Regulatory Affairs Specialist), Regulatory Affairs Level IV (Regulatory Affairs Principal) may also be responsible for the following:

• 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.

 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.

 Qualifications (Experience and Education)

Level

Qualifications

Level I (Associate)

• Bachelor’s Degree in a technical discipline required.
• 0-2 years of medical device Regulatory Affairs 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.
• A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.

Level II (Specialist)

• Bachelor’s Degree in technical discipline required.
• 2-5 years of medical device Regulatory Affairs experience 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.
• Intermediate knowledge of ISO 13485 required.
• Intermediate 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.

Level III (Senior)

• Bachelor’s Degree in a technical discipline required.
• At least 5 years of medical device Regulatory Affairs experience required; 1 year of QMS internal auditing experience required.
• Demonstrated hand on 510K and EU MDR submission experience
• Experience in software as a medical device and digital health
• At least 3 years of experience with global registrations
• 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. 

Level IV (Principal)

• 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.

 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 classifed.