Regulatory & Quality Documentation Specialist

The unique aspect of our business is the mindset of our employees: curious, adventurous, and innovative. P3 consultants take on early responsibilities with clients in management consulting, diverse technology topics, and scalable IT solutions.

Make a project your project. Openness for new, innovative, and unconventional approaches; short decision paths; respectful cooperation; and fruitful synergies make us a diverse, unbeatable team and successful company - worldwide.

WHAT YOU'LL DO

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.

• 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.

WHO YOU ARE

• 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.
• Experience supporting internal or external audits.
• Background in maintaining or remediating quality systems.
• Familiarity with electronic document management systems (eQMS).
• You are comfortable with extensive travel (up to 100% of your working time), typically Monday through Friday, depending on client and project needs.).
• You are legally authorized to work in the U.S.

GOOD TO KNOW

• We offer a competitive salary with bonus potential.
• You get up to 20 days PTO and 10 paid company holidays.
• We offer mentorship and onboarding programs and a flat hierarchy.
• You can get healthcare, life insurance, dental & vision, 401(k) matching.
• We offer national and international travel opportunities.
• You have career opportunities in a fast-growing company and work in small, efficient project teams.