MDSAP Technical Pack Reviewer

SGS

MDSAP Technical Pack Reviewer

Boston, MA +6 locations
Full Time
Paid
  • Responsibilities

    Job Description

    ** Main Purpose of Role**

    • To conduct reviews of MDSAP reports and approve or raise queries based on technical and procedural knowledge
    • Ensure that reviews are technically sound and in compliance with all applicable regulations, standards, guidelines and Competent Authority expectations
    • Ensure that the highest level of service is provided through efficient service delivery and that customer requirements are met
    • Ensure adherence to SGS Policies, procedures and processes
    • As a member of the Global Medical Device office (MDO) to minimise risks associated with medical device certification.

    ** Key Accountabilities**

    • Maintain up-to-date understanding of MDSAP requirement, including all jurisdiction requirements, regulatory transmittals, MDSAP Audit Approach manual, and all associated standards
    • Maintain up-to-date understanding of the MDSAP grading system, corrective and preventive action, and use of the NGE form
    • Review MDSAP audit packs according to specified requirements
    • Generate Query Sheets for any noted deficiencies in the MDSAP audit pack
    • Review and accept/reject query corrections
    • Submit final approved documents to the Global MDSAP administrator for submission to REPS
    • Submit final approved document to the SGS system and approve the MDSAP pack
    • Approve MDSAP certificates after technical approval.
    • Participate in team meetings
    • Maintain on-time reviews based on Regulatory requirements
    • Participate in achievement of KPIs
    • Determine final approval for MDSAP audit packages and the issue of MDSAP certificates
    • Signature authority for final MDSAP reports and NGE
    • If approved as an AO submitter, make submissions to REPS as required
    • Ensure full compliance with the Company’s Code of Integrity & Professional Conduct, and act in accordance with SGS UK’s Equality & Diversity Policy and ensure others do so.
    • At all times, adopt a safe behaviour by exercising due regard for the health and safety of yourself, colleagues and clients, in line with the Company’s policies and procedures.
  • Qualifications

    Qualifications

    ** Skills & Knowledge**

    Essential

    • Medical device knowledge/codes
    • Good communication techniques through electronic mediums
    • Good written English skills (as reports will be reviewed/queried in English)
    • Thorough understand of risk management systems and requirements
    • Customer Focus
    • Teamwork

    Desirable

    • Experience of working to KPI’s
    • Experience of planning own workload/priorities
    • Ability to work with online systems

    ** Experience**

    Essential

    • Four years professional experience in the field of Medical Devices or related activities, (Advanced degrees can substitute for a maximum of three years of working experience)
    • In exceptional cases, a demonstration of equivalent knowledge and skills may be acceptable.
    • Previous MDSAP Lead Auditor Experience

    Desirable

    • Experience as Medical Device audit Technical Reviewer
    • Previous experience working for regulatory jurisdictions or with regulatory requirements of any MDSAP Member country.

    ** Qualifications**

    Essential

    • Successful completion of a university or technical college degree or equivalent qualification in relevant studies e.g. medicine, science, pharmacy, engineering or other relevant sciences
    • MDSAP Lead Auditor Qualification

    Desirable

    • Advanced degrees in engineering, science, or other relevant areas

    Additional Information

    Why SGS?

    • Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry.
    • Enjoy a flexible schedule and work model.
    • Access SGS University and Campus for continuous learning options.
    • Thrive in a multinational environment, collaborating with colleagues from multiple continents.
    • Benefit from our comprehensive benefits platform.

    Join Us: At SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential.

  • Industry
    Facilities Services
  • Locations
    San Francisco, CA • Washington, DC • Atlanta, GA • Boston, MA • Minneapolis, MN • Bloomfield, NJ • Seattle, WA