Inogen
Description
Job Summary
The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device, and de novo devices). The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regulatory standards. Responsibilities
Regulatory Submissions and Compliance:
Develop regulatory strategies to achieve market clearance in an effective and efficient manner Prepare, submit, and maintain product registrations, certifications, and approvals to meet US, EU and other regulatory requirements as applicable:
510(k) and/or De Novo submissions for FDA Technical documentation for EU MDR compliance International product registration activities to meet business objectives
Provide regulatory input to support product labeling Monitor new and changing regulatory requirements and ensure the business understands relevant impacts Lead corrective and preventive action (CAPA) efforts as assigned Product Development Support:
Provide regulatory input throughout the product lifecycle, including design controls, to support regulatory submissions Change Control Management:
Assess and document regulatory impacts of design changes, manufacturing changes, etc., including related updates to product registrations Audits and Inspections:
Support and participate in internal and external audits and regulatory agency inspections QMS Support:
Complete QMS training activities and provide regulatory expertise to continuous improvement activities Support Lean and Kaizen initiatives Comply with all company policies and procedures Assist with any other duties as assigned Qualifications
Education:
Bachelor of Science degree Experience:
5–7 years of regulatory affairs experience in the medical device industry, preferably with respiratory devices Current experience leading multiple successful 510(k) clearances and CE marking is required Experience with additional global regulatory pathways is preferred Technical Skills:
Strong understanding of medical device product life cycle and regulatory requirements In-depth knowledge of ISO 13485, FDA regulations (including 21 CFR Part 820), and EU MDR Knowledge of ISO 14971 risk management for medical devices Proficiency in database systems and advanced Microsoft Excel skills for reporting and analysis Understanding of continuous improvement principles Personal Attributes:
Strong verbal and written communication skills, with the ability to articulate complex technical issues clearly and effectively to cross-functional teams and regulatory bodies Strong analytical and critical thinking skills, with the ability to resolve complex complaints and implement long-term solutions High level of attention to detail and accuracy, particularly when preparing regulatory submissions Inogen assesses market data to ensure a competitive compensation package for our employees. The base salary for this position is expected to be between$99,000 and $119,496.00 annually. However,actualbase salary if hired will be determined on an individualized basisand will be based on non-discriminatory factors, includingas toindividual skills, education,experience and market location. Our Benefits and Rewards: In addition to the expected base salary, this role is eligible to participate inInogen’sannual performance bonus incentive plan,highly competitiveand company-sponsored benefits, and wellbeing programs rooted in our strong culture of excellence. As a valued member of our team, Inogen provideshealth, dental, and vision insurance, 401(k) plan plus employer contribution and match, andgenerous paid leaves such as vacation and sick leave, including paid volunteer time, that can support you and your family through moments that matter. Inogen is an Equal Employment Opportunity/Affirmative Action Employer - Underrepresented racial and ethnic groups/Females/Individuals with Disabilities/Protected Veterans.
The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device, and de novo devices). The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regulatory standards. Responsibilities
Regulatory Submissions and Compliance:
Develop regulatory strategies to achieve market clearance in an effective and efficient manner Prepare, submit, and maintain product registrations, certifications, and approvals to meet US, EU and other regulatory requirements as applicable:
510(k) and/or De Novo submissions for FDA Technical documentation for EU MDR compliance International product registration activities to meet business objectives
Provide regulatory input to support product labeling Monitor new and changing regulatory requirements and ensure the business understands relevant impacts Lead corrective and preventive action (CAPA) efforts as assigned Product Development Support:
Provide regulatory input throughout the product lifecycle, including design controls, to support regulatory submissions Change Control Management:
Assess and document regulatory impacts of design changes, manufacturing changes, etc., including related updates to product registrations Audits and Inspections:
Support and participate in internal and external audits and regulatory agency inspections QMS Support:
Complete QMS training activities and provide regulatory expertise to continuous improvement activities Support Lean and Kaizen initiatives Comply with all company policies and procedures Assist with any other duties as assigned Qualifications
Education:
Bachelor of Science degree Experience:
5–7 years of regulatory affairs experience in the medical device industry, preferably with respiratory devices Current experience leading multiple successful 510(k) clearances and CE marking is required Experience with additional global regulatory pathways is preferred Technical Skills:
Strong understanding of medical device product life cycle and regulatory requirements In-depth knowledge of ISO 13485, FDA regulations (including 21 CFR Part 820), and EU MDR Knowledge of ISO 14971 risk management for medical devices Proficiency in database systems and advanced Microsoft Excel skills for reporting and analysis Understanding of continuous improvement principles Personal Attributes:
Strong verbal and written communication skills, with the ability to articulate complex technical issues clearly and effectively to cross-functional teams and regulatory bodies Strong analytical and critical thinking skills, with the ability to resolve complex complaints and implement long-term solutions High level of attention to detail and accuracy, particularly when preparing regulatory submissions Inogen assesses market data to ensure a competitive compensation package for our employees. The base salary for this position is expected to be between$99,000 and $119,496.00 annually. However,actualbase salary if hired will be determined on an individualized basisand will be based on non-discriminatory factors, includingas toindividual skills, education,experience and market location. Our Benefits and Rewards: In addition to the expected base salary, this role is eligible to participate inInogen’sannual performance bonus incentive plan,highly competitiveand company-sponsored benefits, and wellbeing programs rooted in our strong culture of excellence. As a valued member of our team, Inogen provideshealth, dental, and vision insurance, 401(k) plan plus employer contribution and match, andgenerous paid leaves such as vacation and sick leave, including paid volunteer time, that can support you and your family through moments that matter. Inogen is an Equal Employment Opportunity/Affirmative Action Employer - Underrepresented racial and ethnic groups/Females/Individuals with Disabilities/Protected Veterans.