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 YOULL 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 clients 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.