Senior SW Compliance Specialist – Regulatory Affairs, Design Assurance

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

📋 Description

• Accountable for assisting with Meridian’s regulatory and quality procedures.

• Aid the regulatory team in ensuring product compliance throughout all phases of the product lifecycle.

• Offer support and direction for quality and regulatory tasks, including Design Control activities.

• Contributes to and assists in drafting sections of regulatory submissions for both domestic and global commercialization.

• Prepares, assesses, and reviews technical protocols and data related to clinical trials.

• Evaluates software architecture, requirements, and verification and validation documentation.

• Provides direct assistance regarding adverse events, medical device reportable events, and product recall initiatives.

• Participates in cybersecurity compliance efforts.

⛳️ Requirements

• A Bachelor of Science degree in Biology, Biochemistry, Microbiology, Software Engineering, Computer Science, Computer Engineering, Biomedical Engineering, Electrical Engineering, or another relevant scientific, engineering, or technical field is essential.

• At least 4–6 years of direct experience in Regulatory Affairs, Design Assurance, Software Quality, or a similar regulated industry is required.

• Demonstrated understanding of FDA and ISO regulated environments.

• Experience in the design, development, and clearance processes for medical devices.

• Familiarity with FDA software documentation standards.

• Background in reviewing software lifecycle documentation.

• Working knowledge of cybersecurity requirements relevant to medical devices.

• Capability to evaluate software, firmware, cybersecurity, and connectivity modifications for their regulatory implications.

🏝️ Benefits

• Health insurance.

• Flexible work arrangements.

• Opportunities for professional development.