Regulatory Affairs Specialist III
Katalyst CRO · Richmond, IL · 1 mo ago
On-siteLegalContract
Responsibilities
- 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, including 510(k) and/or De Novo submissions for FDA and technical documentation for EU MDR compliance.
- Conduct international product registration activities to meet business objectives and 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.
- Provide regulatory input throughout the product lifecycle, including design controls, to support regulatory submissions.
- Assess and document regulatory impacts of design changes, manufacturing changes, etc., including related updates to product registrations (Change Control Management).
- 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 the 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.