Subject Matter Expert (SME) – FDA Medical Device Regulations & Quality Assuranc

Job Description

We are seeking an experienced Subject Matter Expert (SME) in FDA Medical Device Regulations with a strong background in Quality Assurance (QA).

In this critical position, this individual will serve as the primary technical authority evaluating compliance, conducting end-to-end Quality Management System (QMS) audits, identifying gaps, and implementing practical remediation strategies and solutions. Experience navigating regulatory frameworks within the oral care or consumer healthcare sector is highly preferred.

Skills and Requirements

• Experience: 8+ years of dedicated experience in Regulatory Affairs and Quality Assurance within the medical device industry.

• Regulatory Expertise: In-depth knowledge of FDA medical device regulations, Quality Management System Regulation (QMSR/QSR), ISO 13485, and 510(k) processes.

• Auditing & Remediation: Proven track record of conducting QMS gap assessments, executing root-cause analysis, and leading hands-on CAPA/remediation projects.

• Preferred Industry Focus: Experience with oral care devices, dental equipment, or OTC consumer healthcare products.

• Education: Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related technical discipline. Regulatory Affairs Certification (RAC) is a plus.

• Conduct comprehensive audits of Quality Management Systems, technical documentation, design controls, and manufacturing processes to identify compliance gaps.

• Perform thorough risk assessments and evaluate CAPA, post-market surveillance, and complaint-handling workflows.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].