Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Ohio.

📋 Description

• Provide support for Regulatory Affairs, Design Quality Assurance, and software compliance initiatives for IVD instruments and related software throughout the entire product development lifecycle.

• Ensure adherence to medical device regulations and standards, including FDA QSR (21 CFR Part 820), ISO 13485, MDSAP, and IVDR.

• Assist in the preparation, submission, and management of regulatory dossiers, Technical Files, and FDA marketing submissions, including 510(k) Pre-Marketing Notifications and Pre-Submissions.

• Aid in the implementation and maintenance of design controls, and review design and development documentation.

• Maintain regulatory files, logs, databases, and ensure the accuracy of records.

• Engage in global regulatory strategy in collaboration with interdisciplinary project teams.

• Support Design Traceability Matrices and ensure traceability between design inputs, outputs, risk controls, and verification and validation activities.

• Facilitate software lifecycle compliance, change control, verification records, and cybersecurity documentation.

• Review and approve technical documentation for products, including requirements, verification/validation documents, safety data sheets, manufacturing procedures, and labeling.

• Assess the regulatory implications of product design changes.

• Author and update regulatory Standard Operating Procedures (SOPs).

• Compile and maintain necessary documentation in accordance with quality system procedures.

• Participate in long-term projects that align with business and quality objectives.

⛳️ Requirements

• Bachelor of Science degree in Biology, Biochemistry, Microbiology, or a related field, along with 2 years of experience in Regulatory Affairs, Quality Assurance, Quality Systems, Design Control, or a comparable role.

• A minimum of one year of direct experience with ISO 14971 Risk Management is required, including the preparation of Risk Management Plans, Hazard Assessments, Usability Engineering, and Human Factors Analysis.

• Experience with design control, product development, validation, and verification activities is preferred.

• Familiarity with IVDR is preferred.

• Experience in supporting regulatory submissions (e.g., 510(k)s, PMAs, and/or international registrations) is strongly preferred.

• Ability to maintain precise and clear records while adhering to regulatory and quality system requirements, including 21 CFR 820, ISO 13485, 2017/746, and SOR/98-282.

• Knowledge of International Registrations, Health Canada, IVDR, and ISO 13485:2016.

• Awareness of IEC 60601, IEC 61010, and IEC 62366 technical standards.

• Ability to work autonomously and collaboratively resolve quality issues.

• Strong organizational skills, attention to detail, prioritization, time management, and the capability to meet deadlines under pressure.

• Exceptional written and verbal communication skills, along with strong interpersonal, problem-solving, and interaction abilities.

• High proficiency in MS Office applications (Word, Excel, PowerPoint, Outlook).

• Willingness to travel as necessary.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance plans.

• Generous paid time off and holiday schedule.

• Opportunities for professional development and career advancement.

• Collaborative work environment with a focus on innovation.