Job Description

Title: Senior Regulatory Affairs and Quality Systems Specialist

The Regulatory Affairs and Quality Systems Specialist is responsible for supporting regulatory and quality assurance processes related to in vitro diagnostic (IVD) medical devices. This organization offers a dynamic and collaborative work environment where you have the opportunity to make a meaningful impact in the field of medical diagnostics. With a focus on innovation and excellence, this company provides ample opportunities for professional growth and development, supporting career advancement through hands-on experience and cross-functional collaboration. You will be empowered to contribute to projects that improve healthcare outcomes globally, particularly in the realm of in vitro diagnostic devices.

Key Responsibilities

• Project Compliance and Oversight: Attend project meetings to ensure all medical device design, development, and manufacturing activities meet regulatory requirements, including U.S. FDA's QSR (21 CFR Part 820), ISO 13485, and other relevant standards.
• Regulatory Strategy Support: Collaborate with internal teams and external partners to develop and implement a global regulatory strategy to meet U.S. FDA requirements and support business goals.
• Quality System Management: Assist in the management of the organization's Quality System in relation to bringing medical device products to market, including document control and regulatory compliance.
• Regulatory Submissions: Provide guidance and support in the drafting and submission of regulatory filings, with a particular focus on FDA Q-Submissions and premarket notifications.
• Clinical and Validation Support: Assist in the preparation and review of technical documents, protocols, and data for clinical trials, validation, verification, and product manufacturing.
• Regulatory Documentation Management: Maintain regulatory files and databases to ensure accuracy and continuity of information across various platforms.
• Process Improvement and SOPs: Draft and update Standard Operating Procedures (SOPs) to ensure they reflect current regulatory practices and requirements.
• Post-market Activities: Manage adverse event reporting, medical device recalls, and product corrections/removals.
• Product Labeling Oversight: Ensure that product labeling, including Instructions for Use (IFU), complies with all applicable regulatory requirements.
• Risk Management and Lifecycle Support: Contribute to risk management activities and assist in monitoring product lifecycle changes.
• Third-Party Audits: Participate in internal and supplier audits, ensuring compliance with regulatory standards and quality system requirements.

Qualifications

• Language Skills: Fluency in English (written and verbal) and Korean (written and verbal) is a Must

• Bachelor's degree in Engineering, Biology, Biochemistry, Microbiology, or a related field.
• 5-6 years of experience in a regulated industry, particularly in medical device quality assurance, regulatory affairs, or quality systems management.
• Experience with FDA and ISO 13485 regulations, including knowledge of IVD medical device regulations, risk management, and design controls.

• Regulatory Expertise: In-depth knowledge of FDA QSR (21 CFR Part 820), ISO 13485, and other relevant standards for medical device manufacturing.
• Problem Solving and Adaptability: Ability to adjust strategies and plans as business needs evolve.
• Stakeholder Communication: Strong interpersonal and communication skills to influence and align stakeholders across the organization.
• Leadership and Organization: Demonstrated leadership ability and project management skills in fast-paced environments.
• Technical Writing: Ability to draft and review complex technical documentation, regulatory submissions, and SOPs.
• Attention to Detail: High level of accuracy in data management and documentation.
• Time Management: Ability to prioritize multiple projects and meet deadlines in a dynamic environment.
• Public Speaking and Training: Experience speaking in large group settings and training teams on regulatory and quality requirements.
• Software Skills: Proficiency with MS Office (Word, Excel, PowerPoint, Outlook) is required.

Travel Requirements:

• Must be willing to travel to US and international based offices

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