Regulatory Affairs Specialist III

Regulatory Affairs Specialist III –
Katalyst CRO

Location:

Austin, TX

Salary: $93,680.00 – $

• 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).
• obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regulatory standards.
• developing regulatory strategies to achieve market clearance in an effective and efficient manner.
• preparing, submitting, and maintaining 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.
• providing regulatory input to support product labelling.
• monitoring new and changing regulatory requirements and ensuring the business understands relevant impacts.
• leading corrective and preventive action (CAPA) efforts as assigned.
• providing regulatory input throughout the product lifecycle, including design controls, to support regulatory submissions.
• assessing and documenting regulatory impacts of design changes, manufacturing changes, etc., including related updates to product registrations.

• Bachelor of Science degree.
• 57 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.
• 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.

Mid‑Senior level

Contract

Legal

Pharmaceutical Manufacturing