Senior Product Assessor, Active Devices in Ellesmere Port
Senior Product Assessor, Active Devices

Senior Product Assessor, Active Devices in Ellesmere Port

Ellesmere Port Full-Time 36000 - 60000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Lead a team of Product Assessors and review technical documentation for Active Medical Devices.
  • Company: Join SGS, the global leader in testing, inspection, and certification.
  • Benefits: Flexible schedule, hybrid work model, and continuous learning opportunities.
  • Why this job: Make a real impact in healthcare by ensuring compliance and quality in medical devices.
  • Qualifications: Experience in product assessment and knowledge of EU regulations required.
  • Other info: Work remotely with a diverse team across Europe and India.

The predicted salary is between 36000 - 60000 £ per year.

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 international culture. We offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include: Integrity, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership.

Are you ready to take your career to the next level? If you have a strong background as a Product Assessor within an EU notified body conducting MDD/MDR technical documentation review, then we have an exhilarating opportunity for you! Join our dynamic team at SGS and become a Senior Product Assessor - Active Devices. This role will allow you to make a significant impact in the field of certification.

As a member of our Medical Device team, you will not only manage a small team of globally based Product Assessors but also dive deep into the exciting world of Active Medical Devices. It is remote based, and we are open to candidates located everywhere across Europe and India. But they must hold a valid work permit for their country of residency.

Your Responsibilities Will Include:

  • 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.

Qualifications

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 is mandatory (as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017): MDA 0304 & MDA 0314 (MUST HAVE).
  • Knowledge of the following Technical File code would be a great addition (as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017): MDA 0203, MDA 0301, MDA 0302, MDA 0303, MDA 0305, MDA 0306, MDA 0308, MDA 0312, MDA 0317

Please submit your CV in English.

Additional Information

Why SGS? Global and very stable company, world leader in the TIC (Testing, Inspection and Certification) industry. Flexible schedule and hybrid model. SGS university and Campus for continuous learning options. Multinational environment where you will work with colleagues from multiple continents. Benefits platform.

Join Us: At SGS we believe in innovation, collaboration, and continuous improvement. We offer a supportive and inclusive work environment that encourages professional growth and personal development.

Senior Product Assessor, Active Devices in Ellesmere Port employer: SGS Australia

At SGS, we pride ourselves on being a global leader in testing, inspection, and certification, offering a dynamic and inclusive work environment that fosters professional growth. As a Senior Product Assessor for Active Devices, you will benefit from our commitment to employee development through continuous learning opportunities and a flexible hybrid work model, all while collaborating with a diverse team across Europe and India. Join us to make a meaningful impact in the field of medical device certification within a company that values integrity, sustainability, and innovation.
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Contact Detail:

SGS Australia Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Senior Product Assessor, Active Devices in Ellesmere Port

✨Tip Number 1

Network like a pro! Reach out to current or former employees at SGS on LinkedIn. A friendly chat can give you insider info and maybe even a referral, which can really boost your chances.

✨Tip Number 2

Prepare for the interview by diving deep into the latest trends in Active Medical Devices. Show us you’re not just knowledgeable but passionate about the field. Bring that enthusiasm to the table!

✨Tip Number 3

Practice your responses to common interview questions, especially those related to team management and technical assessments. We want to see how you handle challenges and support your team.

✨Tip Number 4

Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining our dynamic team at SGS.

We think you need these skills to ace Senior Product Assessor, Active Devices in Ellesmere Port

Technical Documentation Review
EU Regulations Compliance
Team Management
Cross-Functional Collaboration
Recruitment and Onboarding
Training Development and Presentation
Active Medical Devices Knowledge
Standards Knowledge (EN 60601, EN 62304, EN 62366)
Technical File Codes Knowledge (MDA 0304, MDA 0314)
Good Written English Skills
Healthcare Products Experience
Problem-Solving Skills
Attention to Detail
Communication Skills

Some tips for your application 🫡

Tailor Your CV: Make sure your CV is tailored to the Senior Product Assessor role. Highlight your experience with MDD/MDR technical documentation and any relevant projects you've worked on. We want to see how your background aligns with what we're looking for!

Showcase Your Skills: Don’t forget to showcase your knowledge of Active Medical Devices and related standards like EN 60601 and EN 62304. We love seeing candidates who can demonstrate their expertise in these areas, so make it clear in your application!

Be Clear and Concise: When writing your application, keep it clear and concise. Use straightforward language and avoid jargon where possible. We appreciate a well-structured application that gets straight to the point!

Apply Through Our Website: Finally, make sure to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. We can’t wait to see what you bring to the table!

How to prepare for a job interview at SGS Australia

✨Know Your Stuff

Make sure you brush up on your knowledge of Active Medical Devices and the relevant EU regulations. Familiarise yourself with standards like EN 60601 and EN 62304, as well as the Technical File codes mentioned in the job description. Being able to discuss these confidently will show that you're serious about the role.

✨Showcase Your Leadership Skills

Since this role involves managing a team, be prepared to share examples of your leadership experience. Think about times when you've supported or guided a team, conducted training, or handled recruitment. Highlighting these experiences will demonstrate your capability to lead effectively at SGS.

✨Prepare for Technical Questions

Expect some technical questions during the interview, especially related to MDD/MDR documentation reviews. Practice explaining your approach to compliance and how you ensure quality in your assessments. This will help you convey your expertise and problem-solving skills.

✨Ask Insightful Questions

At the end of the interview, don’t forget to ask questions! Inquire about the team dynamics, ongoing projects, or SGS's approach to professional development. This shows your genuine interest in the company and helps you assess if it's the right fit for you.

Senior Product Assessor, Active Devices in Ellesmere Port
SGS Australia
Location: Ellesmere Port
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  • Senior Product Assessor, Active Devices in Ellesmere Port

    Ellesmere Port
    Full-Time
    36000 - 60000 £ / year (est.)
  • S

    SGS Australia

    1000+
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