Regulatory & Quality Documentation Specialist

P3 USA•Greenville, SC

1d•Hybrid

About The Position

Seeking an experienced Regulatory & Quality Documentation Specialist to support critical documentation, compliance, and risk management activities across global markets for our clients. This role will play a key part in maintaining and improving the regulatory backbone of our client's quality system, ensuring alignment with international standards, and supporting ongoing product and process compliance. This is a full-time role that heavily involves reviewing and writing documentation according to ISO 13485 and global compliance.

Requirements

Regulatory Affairs, Quality Management, Biomedical Engineering, Life Sciences, or a related scientific or technical field.
Proven experience in Regulatory Affairs, Quality Assurance, or Document Control within a medical device or other highly regulated industry.
Strong working knowledge of ISO 13485, with hands-on experience in audits to identify gaps and opportunities for improvement.
Familiarity with EU MDR and global regulatory documentation requirements (essential checklist for UK, essential principles for TGA).
Experience with risk management processes (e.g., hazard analysis, risk matrices, FMEA).
Exceptional attention to detail with strong critical thinking and problem-solving skills.
Ability to manage document-heavy workloads with accuracy and efficiency.
Strong organizational and communication skills, with the ability to work across teams in a remote environment.
Familiarity with electronic document management systems (eQMS).
Legally authorized to work in the U.S.

Nice To Haves

Experience supporting internal or external audits.
Background in maintaining or remediating quality systems.

Responsibilities

Update, maintain, and enhance regulatory and quality system documentation, including IFUs, MDFs, EU Technical Files, SOPs, and quality records.
Review and revise risk management documentation, including hazard analyses and risk matrices, ensuring alignment with current standards and product changes.
Support and audit documents in accordance with ISO 13485 requirements.
Ensure consistency, accuracy, and traceability of documentation across systems and platforms (eQMS, website, eIFUs).
Identify gaps or inconsistencies in documentation and proactively recommend improvements.
Support internal or external audits.
Maintain or remediate quality systems.