Quality Assurance/ Regulatory Affairs (QA/RA) Specialist – Medtech

Integration Diagnostics Sweden AB; Göteborgs kommun; On-site; SEK 550,000 - 850,000; Full time

Job summary

Integration Diagnostics Sweden AB is seeking a Quality Assurance/Regulatory Affairs Specialist (Medtech) to join a compact QA/RA team. You will support the QMS documentation, ensure compliance of Technical Documentation, and drive PMS activities under supervision.

The role emphasizes collaboration with QA/RA Manager, maintaining and improving QMS processes, and contributing to regulatory alignment for current and future product portfolios.

Qualifications

• Engineering or scientific degree; Medical Engineering or related field.
• Good knowledge about medical device development.
• Fluent in Swedish and English.

Responsibilities

• Manage document control activities to ensure quality and regulatory documentation is accurate, current, traceable and maintained in compliance with established procedures.
• Maintain Technical Documentation throughout the product lifecycle, ensuring documentation remains complete, current and aligned with product, process and regulatory changes.
• Support Change Management processes by coordinating documentation updates, tracking change actions and ensuring relevant quality and regulatory requirements are addressed.
• Support Post-Market Surveillance (PMS) activities, including collection, review and compilation of complaints, feedback, incidents, trend data and relevant literature.
• Assist in the investigation, documentation and follow-up of nonconformities, corrective and preventive actions (CAPAs), and effectiveness checks.
• Prepare, update and maintain procedures, work instructions, templates, records and other quality and regulatory documentation as assigned.
• Escalate identified compliance gaps, quality issues, documentation deficiencies and potential product safety concerns to designated company representatives.

Job description

Integration Diagnostics and its core products, Penguin RFA and Osseo100 measures dental implant stability to enable clinicians to decide when to load an implant. The technique has been developed in close cooperation with clinicians and experts in the field of dental implantology.

Resonance Frequency Analysis (RFA) and the measurement unit Implant Stability Quotient (ISQ) were introduced into the dental implant industry in 2001 and are now established methods of measuring implant stability and osseointegration.

In 2015, in response to the dental community’s need for an accessible ISQ measuring system, Integration Diagnostics Sweden AB (IDSAB) was founded. Sales have developed rapidly with clients today in + 70 countries globally.

In 2018, Integration Diagnostics became part of the Japanese company Nakanishi Inc. Nakanishi Inc., is a world-leading company of professional dental instruments with the world’s top-share brand “NSK”. All its products are developed and manufactured in Japan and distributed to 135 countries around the globe. The NSK Group has 14 subsidiaries worldwide and has established a strong global sales network.

We are currently looking for a

Quality Assurance/ Regulatory Affairs (QA/RA) Specialist – Medtech

As a QA/RA Specialist, you will be part of a small and agile QA/RA team, working closely with the QA/RA Manager to support the organization in maintaining and organizing required Quality Management System (QMS) documentation and performing assigned Post-Market Surveillance (PMS) activities under the guidance of responsible company personnel.

You will play an active role in maintaining and improving QMS related processes while supporting the development of future innovations within IDSAB's medical device portfolio with establishment and maintenance of technical documentation.

Key responsibilities:

• Manage document control activities to ensure quality and regulatory documentation is accurate, current, traceable and maintained in compliance with established procedures.
• Maintain Technical Documentation throughout the product lifecycle, ensuring documentation remains complete, current and aligned with product, process and regulatory changes.
• Support Change Management processes by coordinating documentation updates, tracking change actions and ensuring relevant quality and regulatory requirements are addressed.
• Support Post-Market Surveillance (PMS) activities, including collection, review and compilation of complaints, feedback, incidents, trend data and relevant literature.
• Assist in the investigation, documentation and follow-up of nonconformities, corrective and preventive actions (CAPAs), and effectiveness checks.
• Prepare, update and maintain procedures, work instructions, templates, records and other quality and regulatory documentation as assigned.
• Escalate identified compliance gaps, quality issues, documentation deficiencies and potential product safety concerns to designated company representatives.

Qualifications

• Engineering or scientific degree, Medical Engineering, or a related field.
• Good knowledge about medical device development
• Fluent in Swedish and English

Preferred Experience

The following experience is considered an advantage:

• Quality Management systems, ISO 13485 or similar
• Regulations: EU MDR or similar
• Previous experience within the medical device industry is highly valued.

To succeed in this role, you are a person with the following skills:

• Strong communication
• Self-leadership
• Quality awareness
• Structured approach to work
• Conscientious and responsible

You will be part of an exciting and challenging journey shaping the company’s future and taking the business to new heights. In this role you will have a great opportunity to make an impact and improve our future supply to the market.

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