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Senior Product Assessor - Active Devices

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Afterpay

Jan 8, 2025

Applications are closed

  • Job
    Full-time
    Mid Level
  • Healthcare
    Product
  • Madrid
    Remote

Requirements

  • To be eligible for this role, you should have prior experience as a Product Assessor/Specialist/Technical File Reviewer within another Notified Body for active devices, conducting reviews against MDD and/or MDR.
  • Additionally, you must possess:
  • Four years of professional experience in the field of healthcare products or related activities, such as design, manufacturing, auditing, or research, of which two years shall be in the design, manufacture, testing, or use of the device or technology to be assessed or related to the scientific aspects to be assessed;
  • Active Medical Devices knowledge (monitoring equipment, therapeutic devices, devices utilizing radiation, stand-alone software devices, etc.) through designing, manufacturing, or testing of such devices;
  • Thorough knowledge and understanding of related standards: EN 60601, EN 62304, EN 62366, etc.;
  • Good written English skills (as reports will be reviewed/queried in English);
  • Knowledge of the following Technical File codes desirable (as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017): MDA0201, MDA0202, MDA0203, MDA0204, MDA0301, MDA0302, MDA0303, MDA0304, MDA0305, MDA0306, MDA0307, MDA0308, MDA0309, MDA0310, MDA0311, MDA0312, MDA0313, MDA0314, MDA0315, MDA0316, MDA0317, and MDA0318.

Responsibilities

  • Supporting and guiding your team of talented Product Assessors
  • Conducting thorough technical documentation reviews and ensuring compliance with EU regulations and standards.
  • Collaborating with cross-functional teams to increase efficiency and quality
  • Monitoring the team's technical competence, KPIs, and wellbeing and providing feedback and support when there are concerns.
  • Conduct recruitment, including reviewing CVs and undertaking interviews and supporting with onboarding of new starters
  • Develop training and present the training to others in SGS or externally as deemed necessary.
  • Assist with technical queries and those related to sales within the Active Medical Devices field.
  • Ensure that the highest level of service is provided throughout the SGS network offering medical devices certification and stakeholders through efficient service delivery.

FAQs

What is the job title for this position?

The job title is Senior Product Assessor - Active Devices.

What company is hiring for this role?

The hiring company is SGS, the world's leading testing, inspection, and certification company.

What qualifications are required for this position?

Candidates should have prior experience as a Product Assessor/Specialist/Technical File Reviewer within another Notified Body for active devices, along with four years of professional experience in healthcare products or related fields.

Is experience with active medical devices necessary?

Yes, candidates must have knowledge of Active Medical Devices through experience in their design, manufacturing, or testing.

What specific standards should candidates be familiar with?

Candidates should have thorough knowledge and understanding of related standards such as EN 60601, EN 62304, and EN 62366.

Will there be opportunities for training and development?

Yes, you will have the opportunity to develop training materials and present training both inside and outside of SGS as deemed necessary.

Are there benefits included with this position?

Yes, SGS offers a comprehensive benefits platform as part of the employment package.

What is the work schedule like?

The position offers a flexible schedule and a remote work model.

Will I be managing a team in this role?

Yes, you will be responsible for supporting and guiding a small team of globally based Product Assessors.

What language skills are required for this position?

Good written English skills are necessary, as reports will be reviewed/queried in English.

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Afterpay

Finance
Industry
501-1000
Employees

Mission & Purpose

Afterpay is a financial technology company that offers a "buy now, pay later" service, allowing consumers to make purchases and pay for them in four interest-free instalments. Their goal is to provide a flexible and convenient payment solution that helps shoppers manage their finances without incurring debt. By partnering with various retailers, Afterpay aims to enhance the shopping experience and support responsible spending habits. Their purpose is to empower consumers with financial freedom while driving sales for merchants.

Culture & Values

  • We’re brave with our decisions.

  • We keep it real with our actions.

  • We do the right thing for all stakeholders.

  • We shape the future with passion.