Conduct AML periodic and event-driven merchant reviews, assess risk ratings and due diligence needs, manage complex cases, and document decisions to maintain regulatory compliance and support ongoing monitoring.
Regulatory Affairs Specialist II
📜 Description
- Prepare regulatory submissions for clinical research, export, and commercial distribution, including IDE, 510(k), CE-Mark, and UKCA packages.
- Track concurrent projects and maintain existing approvals and documentation.
- Coordinate with in-country regulatory personnel and communicate with regulatory agencies under supervision.
- Research competitor FDA clearances and approvals, sharing relevant findings with stakeholders.
- Review design control, quality system, labeling, and risk management documents for regulatory compliance.
- Support strategic research, improve procedures and work instructions, and assist with Field Corrective Actions.
🛠️ Requirements
- Bachelor's degree in a science discipline or related field and 2+ years of experience, or equivalent education and experience.
- Medical device regulatory affairs experience preferred.
- Ability to apply technical standards, principles, concepts, and techniques.
- Strong oral, written, and interpersonal communication skills; accuracy and attention to detail.
- Proficiency with MS Word, Excel, and PowerPoint; strong organization and prioritization skills.
✨ Benefits
- A collaborative teamwork environment where learning is constant, and performance is rewarded.
Full job description
• Track multiple projects concurrently
• Ensure that existing approvals and documentation are maintained
• Communicate with in-country RA personnel to facilitate global clearance/approvals
• Monitor, research, and obtain information on FDA clearances/approvals of competitors, and proactively share this information with interested parties
• Communicate with regulatory agencies under direct supervision
• Perform reviews with some oversight of design control documents (e.g., engineering protocols, reports, product drawings, etc.), quality system procedures relating to commercialization, labeling (e.g., Instructions for Use, product labels, promotional materials), and risk management to ensure regulatory compliance.
• Assist in performing moderately complex research to support strategic planning
• Analyze existing systems and procedures, recommend solutions/improvements, and write or revise Work Instructions and SOPs as needed to support departmental functions and the Quality System
• Understand the Quality System, biocompatibility requirements, Design Control, Medical Device Directive, Essential Requirements, ISO 13485, labeling requirements, Quality System Regulation, Canadian regulations, export requirements, and regulatory requirements of pertinent regions
• Assist in activities (e.g., execution, documentation) related to Field Corrective Actions.
• Regulatory Medical Device experience preferred
• Proven ability to use and apply technical standards, principles, theories, concepts, and techniques.
• Strong oral, written, and interpersonal communication skills
• High degree of accuracy and attention to detail
• Proficiency with MS Word, Excel, and PowerPoint
• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously
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