5-7 years of regulatory affairs experience in medical device industry, preferably with respiratory devices
Strong understanding of medical device product life cycle and regulatory requirements
In-depth knowledge of ISO 13485, FDA regulations (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
Strong verbal and written communication skills for articulating complex technical issues
Strong analytical and critical thinking skills for resolving complaints
High level of attention to detail and accuracy
Responsibilities
Oversee global product registrations and ensure regulatory compliance for medical devices
Develop and execute regulatory strategies for efficient market clearance
Prepare and maintain regulatory submissions for US, EU, and other markets
Handle 510(k) and/or De Novo submissions for FDA
Ensure technical documentation compliance with EU MDR
Monitor changing regulatory requirements and assess impacts on business operations
Support product development with regulatory insights throughout lifecycle
Lead and manage corrective and preventive action efforts as assigned
Prepare for and participate in audits and regulatory agency inspections
Benefits
Comprehensive medical, dental, and vision insurance
401(k) plan with company match
Paid time off and holidays
Professional development opportunities
Flexible work arrangements
Full Job Description
Responsibilities:
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)
The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regulatory standards
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 labelling
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:
ssess and document regulatory impacts of design changes, manufacturing changes, et al, including related updates to product registrations
udits and Inspections:
Support and participate in internal and external audits and regulatory agency inspections.
Requirements:
Bachelor of Science degree
5-7 years of regulatory affairs experience in medical device industry, preferably with respiratory devices
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
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
