MDSAP Technical Pack Reviewer

1 week ago

Toronto, Ontario, Canada SGS Full time
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

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. 

  • MDSAP Technical Pack Reviewer

    9 hours ago

    Toronto, Ontario, Canada SGS Full time

    We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. At SGS, we have an open corporate and...

  • MDSAP Technical Reviewer

    7 days ago

    Toronto, Ontario, Canada SGS Full time

    Job DescriptionTo conduct thorough reviews of MDSAP reports and make informed decisions on approval or raising queries based on technical and procedural knowledge.Ensure adherence to our policies, procedures, and processes.Maintain a strong understanding of MDSAP requirements, including jurisdictional requirements, regulatory transmittals, and associated...

  • Medical Device Technical Review Specialist

    8 hours ago

    Toronto, Ontario, Canada SGS Full time

    We are SGS, a world-leading testing, inspection and certification company. Our global benchmark for sustainability, quality and integrity drives our mission to enable a better, safer and more interconnected world.As a dynamic and professional workplace, we foster an open corporate and international culture that values teamwork, diversity and continuous...

  • MDSAP Audit Compliance Expert

    4 hours ago

    Toronto, Ontario, Canada SGS Full time

    Becoming part of SGS means joining a globally recognized and stable company at the forefront of the Testing, Inspection, and Certification industry.This role offers a flexible schedule, access to continuous learning options through SGS University and Campus, and the opportunity to thrive in a multinational environment collaborating with colleagues from...

  • Reviewer

    5 days ago

    Toronto, Ontario, Canada SGS Full time

    We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. At SGS, we have an open corporate and international culture. Our high professional standards and our sustainability approach...

  • Reviewer - Medical

    1 week ago

    Toronto, Ontario, Canada SGS Full time

    We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. At SGS, we have an open corporate and international culture. Our high professional standards and our sustainability approach...

  • Reviewer - Medical

    1 week ago

    Toronto, Ontario, Canada SGS Full time

    We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. At SGS, we have an open corporate and international culture. Our high professional standards and our sustainability approach...

  • Global Medical Device Auditor

    1 week ago

    Toronto, Ontario, Canada SGS Full time

    Job DescriptionTo conduct reviews of MDSAP reports and approve or raise queries based on technical and procedural knowledge, ensuring 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. Maintain up-to-date understanding of MDSAP requirement,...

  • Technical Claims Review and Compliance Expert

    6 days ago

    Toronto, Ontario, Canada Zurich Australian Insurance Ltd. Full time

    Zurich Canada is seeking a highly skilled Technical Claims Review and Compliance Expert to join our team. This is a great opportunity for an experienced professional to utilize their skills and expertise in technical claims review and compliance.About the CompanyZurich Canada is part of the Zurich Insurance Group, a multi-line insurer with approximately...

  • Technical Product Developer

    1 week ago

    Toronto, Ontario, Canada Strider Apparel Full time

    Are you a talented Technical Product Developer looking for a new challenge? Do you have experience in technical design and a passion for creating high-quality products?We are seeking a skilled Technical Product Developer to join our design team at Strider Apparel. As a key member of our team, you will be responsible for developing new products and product...

  • Technical/Assistant Designer

    1 week ago

    Toronto, Ontario, Canada Strider Apparel Full time

    Company Description Strider Apparel specializes in private label knitwear, underwear and formal accessories for retailers across the country. This is a full-time, remote role for a Technical/Assistant Designer. We are seeking a technical designer with 5+ years in a similar role. The role involves tasks such as tech pack creation/modification, sample...

  • Technical/Assistant Designer

    5 days ago

    Toronto, Ontario, Canada Strider Apparel Full time

    Company Description Strider Apparel specializes in private label knitwear, underwear and formal accessories for retailers across the country. This is a full-time, remote role for a Technical/Assistant Designer. We are seeking a technical designer with 5+ years in a similar role. The role involves tasks such as tech pack creation/modification, sample...

  • Technical Design Professional

    6 days ago

    Toronto, Ontario, Canada Strider Apparel Full time

    About Strider Apparel:">At Strider Apparel, we specialize in private label knitwear and underwear for top retailers across the country. Our goal is to deliver exceptional quality products while maintaining efficient communication with our overseas partners. Job Responsibilities:">As a Technical/Assistant Designer, you will be responsible for creating and...

  • Technical Solutions Expert

    6 days ago

    Toronto, Ontario, Canada Global Technical Talent Full time

    Job Overview:We are seeking a seasoned Solutions Architect to lead our team in designing, implementing, and maintaining large-scale enterprise solutions. The ideal candidate will have a strong background in software development, architecture, and technical leadership.About the Role:The successful candidate will be responsible for analyzing business...

  • Technical Architecture

    3 weeks ago

    Toronto, Ontario, Canada Tundra Technical Solutions Inc. Full time

    Reporting to the Senior Project Manager and/or Project Manager, the Data Centre Specialist will be the subject matter expert and lead, working in collaboration with other team leads, providing technical guidance, overall strategy, planning, design, overseeing execution, and commissioning of the Data Centre/Computer Room upgrade project. The specialist will...

  • Infrastructure Designer and Reviewer

    1 week ago

    Toronto, Ontario, Canada Apex Systems Full time

    Apx Systems is seeking a highly skilled Infrastructure Designer and Reviewer to join our team.The successful candidate will be responsible for designing and reviewing technical education content. This role involves creating and reviewing training materials for Cisco certifications, products, and solutions.The key responsibilities of this position...

  • BPV Junior Technical Specialist

    7 days ago

    Toronto, Ontario, Canada Technical Standards & Safety Authority Full time

    Since 1997, the Technical Standards and Safety Authority (TSSA) has delivered public safety services on behalf of the government of Ontario. With headquarters in west Toronto, the TSSA is a self-funded, not-for-profit organization that employs approximately 450 staff across Ontario. The roles within the TSSA are as diverse as the Province we serve. It takes...

  • Integration Technology Specialist

    1 week ago

    Toronto, Ontario, Canada Pack-Smart Inc. Automation Full time

    Pack-Smart Inc. Automation is seeking a skilled professional to drive seamless integration of CAD and ERP systems, enhancing collaboration and improving project outcomes.Job ResponsibilitiesKey responsibilities include:Liaising with departments to integrate systems seamlessly and align technology solutions with overall business objectives.Collaborating with...

  • CAD ERP System Analyst

    1 week ago

    Toronto, Ontario, Canada Pack-Smart Inc. Automation Full time

    As a key member of our team, you'll play a critical role in engineering seamless integration of CAD and ERP systems at Pack-Smart Inc. Automation.Key ResponsibilitiesResponsibilities include:Liaising with departments to integrate systems seamlessly and align technology solutions with overall business objectives.Collaborating with stakeholders and team...

  • Business Solutions Expert

    1 week ago

    Toronto, Ontario, Canada Pack-Smart Inc. Automation Full time

    At Pack-Smart Inc. Automation, we're pushing the boundaries of innovation and excellence in system integration.Company OverviewWe're a dynamic team dedicated to engineering seamless integration of CAD and ERP systems, driving smooth data exchange, streamlined workflows, enhanced collaboration, and improved project outcomes.Job DescriptionAs our ideal...