Medical Device Lead Auditor

Avetix Engineering; Massachusetts; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

International work environment

Competitive compensation package

Professional development and training

Job summary

Avetix Engineering seeks an experienced Medical Device Lead Auditor to join a leading Notified Body. You will plan and conduct third-party audits of manufacturers' QMS and technical documentation against ISO 13485, EU MDR/IVDR, and FDA QSR.

The role requires leading audit teams, assessing devices from Class I to III, identifying nonconformities, and reporting findings. Travel is expected as part of audits globally.

Qualifications

• Degree or post-graduate degree in scientific disciplines such as Biomedical Engineering, Biotechnology, Biology, Chemistry, Pharmacy, Bioengineering, or equivalent field.
• Notified Body Auditor experience required.
• Ability to travel.

Responsibilities

• Evaluate QMS against ISO 13485 requirements to ensure conformity and continuous improvement.
• Plan, lead, and report on initial, surveillance, and recertification audits against ISO 13485, EU MDR/IVDR, and other applicable standards.
• Conduct document reviews, on-site inspections, and remote audits evaluating QMS and technical documentation for regulatory compliance.
• Assess conformity of medical devices across classes (EU I–III; US II/III), including SaMD and combination products.
• Identify nonconformities, assign classifications, and document findings clearly.
• Lead audit teams as the audit team leader (ATL), coordinating experts and auditors as required.

Skills

Auditing

Regulatory compliance

Team leadership

Education

Biomedical Engineering

Biotechnology

Biology

Chemistry

Pharmacy

Bioengineering

Job description

We are seeking an experienced a Medical Device Lead Auditor join a leading Notified Body. In this role, you will play a critical part in evaluating the safety, performance, and regulatory compliance of medical devices from manufacturers worldwide. You will plan and conduct third-party audits of medical device manufacturers' quality management systems and technical documentation against applicable regulatory requirements, including ISO 13485, EU MDR 2017/745, IVDR 2017/746, and FDA Quality System Regulation (21 CFR Part 820 / QMSR).

KEY RESPONSIBILITIES

• Evaluate Quality Management Systems (QMS) against ISO 13485 requirements to ensure conformity and continuous improvement
• Plan, lead, and report on initial, surveillance, and recertification audits of medical device manufacturers against ISO 13485, EU MDR/IVDR, and other applicable standards.
• Conduct thorough document reviews, on-site inspections, and remote audits, evaluating quality management systems and technical documentation for regulatory compliance.
• Assess conformity of medical devices ranging from Class I/IIa/IIb/III (EU) and Class II/III (US), including software as a medical device (SaMD) and combination products.
• Identify nonconformities, assign appropriate classifications (major/minor/observation), and document findings clearly and objectively.
• Lead audit teams as the audit team leader (ATL), coordinating the work of technical experts, product specialists, and other auditors as required.

REQUIRED QUALIFICATIONS

• Degree or post-graduate degree in scientific disciplines such as Biomedical Engineering, Biotechnology, Biology, Chemistry, Pharmacy, Bioengineering, or equivalent field
• Previous Notified Body Auditor Experience
• Ability to travel
• Familiarity with EU MDR 2017/745 and IVDR 2017/746 requirements, including Annex IX, X, and XI conformity assessment routes.
• Experience in one or more specialized product areas such as active implantable devices, in vitro diagnostics, software as a medical device (SaMD), sterile devices, or orthopedic implants.
• MDSAP qualified is preferred
• Knowledge of international regulatory frameworks beyond EU and US, such as Health Canada, TGA (Australia), or ANVISA (Brazil).

WHAT WE OFFER

• Opportunity to work with cutting-edge medical technologies
• Professional development and training in regulatory affairs
• International work environment with diverse client portfolio
• Competitive compensation package