Tampere
IVD Specialist
At a glance
IVD Specialist in Tampere, Finland; regulatory auditing and certification support for medical devices.
Original job descriptionJob description
IVD Specialist to work in Kiwa Sertio’s Notified Body for in vitro diagnostic medical devices. Responsibilities include evaluating regulatory compliance, conducting audits, reporting, and supporting certification decisions for IVD products, while aligning with the Notified Body's quality management system. The role involves collaboration with various IVD stakeholders in a highly regulated environment, applying knowledge of regulatory requirements, quality management, and product evaluation, and ensuring assessments are performed to high standards, on time and with independence. The expert group supports regulatory assessments and inspections, and ongoing professional development to follow IVDR/MDCG guidelines and evolving standards. Travel may be required both in Finland and abroad. The office is in Tampere.
The text above is the employer's original job description, extracted as written. Other details on this page, like salary, responsibilities, and requirements, are interpreted from that text by our system, not values the employer explicitly confirmed, so treat them as our best interpretation rather than verified facts.
Skills & Technologies
Knowledge Of EU IVDR And Regulatory Requirements For In Vitro Diagnostic DevicesQuality Management Systems (ISO 13485)Regulatory Auditing And AssessmentTechnical Documentation Review And ReportingStrong Analytical And Interpreting SkillsExcellent Written And Verbal Communication In Finnish And English
Education Level
BachelorHow this salary compares
Estimated €2,500 - €3,071Est. take-home €2,057 - €2,423
Estimated from 2,875 comparable listings
15% below this company
€2,080€2,786 median€4,500
| Market | Lower bound (25th percentile) | Median | Upper bound (75th percentile) |
|---|---|---|---|
| this company | €2,240 per month | €2,786 per month | €3,680 per month |
| This offer | €2,500 per month | €2,786 per month | €3,071 per month |
Responsibilities
- Assess regulatory compliance of medical devices under the EU IVDR, participate in audits and assessments, prepare and review documentation, support certification decisions, and contribute to the development of assessment practices.
- Collaborate with internal and external stakeholders, stay updated on IVDR/MDCG guidelines and standards, and assist in regulatory inspections and surveillance.
- Provide training and knowledge sharing within the expert group and maintain professional integrity and independence in evaluation.
Requirements
- Higher education degree in a relevant field (e.g., microbiology, chemistry, biochemistry, biotechnology, biology, genetics) or another suitable university degree.
- Experience in IVD regulatory affairs, quality management, product development, manufacturing or technical documentation.
- Prefer previous IVD assessment or audit experience and/or work in a Notified Body; ISO 13485 external audits and certification body qualifications are a plus.
Recruitment Process
- Submit application with CV and cover letter
- Interviews may follow
- Reference checks
Financial overview
€33.0M
Revenue
€860.0K
Profit
3.0%
Profit margin
KiwaSuomi · 3 open roles
Top locations (all time): Helsinki, Finland · 7 · Tampere, Finland · 2 · Vantaa, Finland · 2 · +6 other locations
| Location | Active listings |
|---|---|
| Helsinki, Finland | 7 |
| Tampere, Finland | 2 |
| Vantaa, Finland | 2 |
| Remote - Global | 2 |
| Pori, Finland | 1 |
| Seinäjoki, Finland | 1 |
| Turku, Finland | 1 |
| Rauma, Finland | 1 |
| Remote - Finland | 1 |
| Role type | Active listings |
|---|---|
| Open Application | 2 |
| Customer Service Coordinator | 1 |
| Fullstack Developer | 1 |
| Crane and Hoist Inspection Specialist | 1 |
| Fire Alarm System Inspector | 1 |
| Lead Auditor | 1 |
| Nostolaitetarkastaja | 1 |
| Calibrator / Measurement Specialist | 1 |
| Hoist Equipment Inspector | 1 |
| Sales Manager | 1 |
| NDT Inspector | 1 |
| Chief Assessor | 1 |
| IVD Specialist | 1 |
| Role level | Active listings |
|---|---|
| Mid-Level | 12 |
| Senior | 1 |
| Manager | 1 |
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