- ಅನುಭವ
- 4+ ವರ್ಷಗಳು
- ಸಂಬಳ
- —
- ತೆರೆಯುವಿಕೆಗಳು
- 1
- ಪೋಸ್ಟ್ ಮಾಡಲಾಗಿದೆ
- 13 ಗಂಟೆಗಳ ಹಿಂದೆ
- ಕೆಲಸದ ಮೋಡ್
- ಮನೆಯಿಂದ ಕೆಲಸ ಮಾಡಿ
- ವಿದ್ಯಾಭ್ಯಾಸ
- Bachelor’s degree in a scientific or engineering discipline relevant to medical devices
- ಪುನರಾರಂಭ
- ಅರ್ಜಿ ಸಲ್ಲಿಸಲು ಕಡ್ಡಾಯ
ಕೆಲಸದ ವಿವರ
About the Role
We are seeking an experienced Lead Auditor specializing in medical devices to support the evaluation of cutting-edge health technologies and ensure adherence to top-tier regulatory standards. This contractor position, based in Ireland, offers remote work flexibility and focuses primarily on assessing Quality Management Systems (QMS) of companies developing innovative medical devices.
Key Responsibilities
- Perform independent remote audits of medical device manufacturers' QMS in line with ISO 13485, EU MDR, and UK MDR standards.
- Analyze objective evidence, determine audit findings, and produce detailed audit reports with precise conclusions.
- Maintain compliance with established audit procedures, uphold high-quality expectations, and apply relevant regulatory principles.
- Provide consistent, professional audit experiences while contributing to the enhancement of auditing processes.
- Exercise sound regulatory judgment by interpreting requirements and ensuring compliant evaluations.
Candidate Requirements
- A bachelor’s degree in relevant science or engineering fields such as software engineering, computer science, physics, biophysics, biology, microbiology, chemistry, biochemistry, electrical/electronic/mechanical engineering, bioengineering, human physiology, medicine, or pharmacy.
- At least 4 years of professional experience within the medical device sector.
- Minimum 2 years auditing or managing Quality Management Systems according to ISO 13485 and either EU MDR or UK MDR.
- Previous experience serving as a Lead Auditor within notified or accreditation bodies.
- Strong expertise in medical device regulations, standards including ISO 14971, IEC 62304, IEC 82304, and cybersecurity considerations.
- Experience in auditing software as a medical device (SaMD) is highly regarded.
- Excellent communication skills for clearly articulating audit findings and regulatory expectations.
- High degree of autonomy, dependability, and meticulousness in handling audit tasks.
- Willingness to adopt structured auditing methods, tools, and quality-focused practices.
Benefits and Working Conditions
- Flexible contractor engagement tailored to audit volume and your availability.
- Fully remote work setup supporting work-life balance.
- Opportunity to participate in enabling rapid access to safe and effective healthcare innovations.
- Autonomy in managing audits with collaboration within a quality-focused team environment.
- Exposure to advanced medical device companies and emerging health technology solutions.
- Chance to broaden regulatory skills in a fast-growing sector.
Additional Information
This role is coordinated through a partner company who manages application review and subsequent steps. The hiring process incorporates an AI-driven matching system to ensure an objective and timely consideration of candidates against core role requirements. The final recruitment decisions, including interviews and assessments, are conducted by the partner company.
Data Privacy: By applying, candidates consent to the processing of their personal information in alignment with applicable data protection laws including GDPR. AI tools may be employed during recruitment to assist but do not replace human judgement. Candidates can request information about data processing or exercise their data rights anytime.