What are the responsibilities and job description for the Regulatory Affairs Specialist position at Katalyst CRO?
Responsibilities
- The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regulatory standards.
- The Regulatory Affairs 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).
- 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.
- Provide regulatory input throughout the product lifecycle, including design controls, to support regulatory submissions.
- Assess and document regulatory impacts of design changes, manufacturing changes, et al, including related updates to product registrations.
- Support and participate in internal and external audits and regulatory agency inspections.
- Complete QMS training activities and provide regulatory expertise to continuous improvement activities.
- Comply with all company policies and procedures.
- 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.