Experienced Premium Insurance Field Auditor
EXL
Clinical Practice Auditor
RQM+
contract
Posted on:
Location Type: Hybrid
Location: 🇩🇪 Germany
Visit company websiteJob Level
SeniorLead
Tech Stack
Google Cloud Platform
About the role
- Responsible for project management, audit planning, executing the audit within the allotted time, issuing the audit report within the allotted time and the approval of the final audit report.
- Providing the clients with 80% auditor (hats on) and 20% mentor (hats off).
- Responsible for identifying opportunities where RQM+ can provide additional support and assistance to the client. These opportunities shall be fed back to the RQM+ business development team.
- Supporting the training and development of junior auditors, providing them with guidance and support.
- Identifying and supporting the development of training modules required by the Audit Practice.
- Maintaining their training in new / revised regulations, standards and guidances as they become available.
- This is a client facing role and the ideal candidate must have the quiet authority and confidence to arrange and host client meetings and conduct the audits.
- As an auditor there will be challenging situations and difficult conversations with the client. The candidate must have the strength of character to manage these situations with tact, diplomacy and integrity. Admit when they are wrong and maintain their position when they are right.
Requirements
- A professional and qualified Medical Device lead auditor, with 10+ years of experience in the Clinical Research (specifically, Medical Device) industry.
- Expertise in Good Clinical Practice must include 21 CFR, ISO14155, ICH GCP.
- Expertise in FDA BIMO Audit expectations is highly desirable.
- ISO20916 and EU IVDR are also highly desirable.
- Robust auditing experience.
- Fluent in German and English.
- A university degree, or equivalent in science or nursing.
Benefits
- Providing a rewarding place to work is rooted deep in our core values.
- Industry leading compensation package.
- Focus on work life balance.
- Ongoing learning and development opportunities.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
auditingproject managementclinical researchGood Clinical Practice21 CFRISO 14155ICH GCPFDA BIMO AuditISO 20916EU IVDR
Soft skills
mentoringclient managementtactdiplomacyintegritycommunicationleadershipproblem-solvingtraining developmentstrength of character
Certifications
Medical Device lead auditor
