Quality & Regulatory Manager

Rarity Bioscience AB; Uppsala kommun; On-site; SEK 900,000 - 1,200,000; Full time

Job summary

Rarity Bioscience AB is seeking a hands-on Quality and Regulatory Manager to transition our molecular diagnostics technology from research into clinical practice. You will own day-to-day quality and regulatory activities across the product lifecycle and work closely with Product Development, Product Management and Operations.

You will manage interactions with Notified Bodies and authorities, ensure documentation compliance (EU IVDR, ISO 13485), and contribute to market access strategies while

Qualifications

• Hands-on experience in medical device or IVD regulation and quality.
• Proactive, self-driven and collaborative mindset.
• Ability to translate regulations into workable solutions.

Responsibilities

• Represent Quality & Regulatory in new product development and product lifecycle projects.
• Provide impact assessments for design, manufacturing, process and supplier changes.
• Prepare, review and maintain regulatory technical documentation, including EU IVDR requirements.
• Manage interactions with Notified Bodies and regulatory authorities.
• Monitor regulatory intelligence and global requirements for products and operations.
• Review customer materials for regulatory compliance.
• Represent QA/Regulatory during internal and external audits.
• Support market access activities, starting with CE marking under EU IVDR.
• Conduct annual product dossier reviews and post-market surveillance documentation.
• Support QMS processes including complaints, change control, CAPA, and audits.
• Drive continuous improvement of the QMS in line with ISO 13485 and regulatory requirements.

Education

BSc or higher in life sciences, pharmacy, biomedical engineering, chemistry, or related field

Job description

Kommun: Uppsala

Rarity Bioscience is looking for a hands-on Quality and Regulatory Manager to help transition our innovative molecular diagnostics technology from research use into clinical practice. This is a broad and operational role for someone who enjoys working close to both the science and the regulatory framework that enables products to reach patients.

As part of a small Quality & Regulatory team, the successful candidate will take ownership of day-to-day quality and regulatory activities across the product lifecycle. The role spans both Regulatory Affairs and Quality Management, with responsibilities including supporting product development projects, maintaining technical documentation, handling interactions with Notified Bodies and authorities, overseeing post-market surveillance activities and ensuring compliance with applicable regulations and standards such as EU IVDR and ISO 13485.

The position offers significant influence and visibility within the company. Working closely with Product Development, Product Management and Operations, the Quality and Regulatory Manager will act as a key business partner, helping shape regulatory strategy, support market access initiatives and ensure that quality and compliance considerations are integrated into decision-making.

The position is based at our office in Uppsala. We work on-site at least three days per week and you will be part of a small Quality & Regulatory team, reporting to the Director of Operations, Quality & Regulatory.

The Role

Rarity Bioscience is looking for a hands-on Quality and Regulatory Manager to help transition our innovative molecular diagnostics technology from research use into clinical practice. This is a broad and operational role for someone who enjoys working close to both the science and the regulatory framework that enables products to reach patients.

As part of a small Quality & Regulatory team, the successful candidate will take ownership of day-to-day quality and regulatory activities across the product lifecycle. The role spans both Regulatory Affairs and Quality Management, with responsibilities including supporting product development projects, maintaining technical documentation, handling interactions with Notified Bodies and authorities, overseeing post-market surveillance activities and ensuring compliance with applicable regulations and standards such as EU IVDR and ISO 13485.

The position offers significant influence and visibility within the company. Working closely with Product Development, Product Management and Operations, the Quality and Regulatory Manager will act as a key business partner, helping shape regulatory strategy, support market access initiatives and ensure that quality and compliance considerations are integrated into decision-making.

The position is based at our office in Uppsala. We work on-site at least three days per week and you will be part of a small Quality & Regulatory team, reporting to the Director of Operations, Quality & Regulatory.

Duties & Responsibilities

• Represent Quality & Regulatory in new product development and product lifecycle management projects.

• Provide impact assessments for design, manufacturing, process and supplier changes.

• Prepare, review and maintain regulatory technical documentation, including documentation required under EU IVDR.

• Manage interactions with Notified Bodies and regulatory authorities, including submissions and change notifications.

• Participate in regulatory intelligence activities and monitor global regulatory requirements applicable to our products and operations.

• Review customer-facing materials, including data sheets, user manuals and website content, for accuracy and regulatory compliance.

• Represent the Quality & Regulatory function during internal and external audits.

• Contribute to market access activities supporting expansion into new markets, beginning with CE marking under EU IVDR.

• Conduct annual product dossier reviews and maintain post-market surveillance documentation.

• Support Quality Management System processes, including complaint handling, change control, CAPA, management review and audits.

• Drive the continuous improvement and effectiveness of the Quality Management System, ensuring compliance with ISO 13485 and applicable regulatory requirements.

Your Profile

The ideal candidate has several years of hands-on experience within the medical device or IVD industry, a practical understanding of quality and regulatory requirements, and the ability to translate regulations into workable solutions. Success in the role requires a proactive, self-driven and collaborative mindset, as well as the confidence to operate in a fast-moving scale-up environment where priorities evolve and individuals are expected to take ownership beyond their job description.

Documented hands-on experience in medical device and/or IVD compliance management is a firm requirement for this role.

Competencies & Areas of Expertise

• BSc degree or higher in life sciences, pharmacy, biomedical engineering, chemistry, or a related field.

• 5+ years of experience in a regulated medical device or IVD environment.

• Documented hands-on experience in regulatory affairs and/or quality management for medical devices or IVDs.

• Solid understanding of ISO 13485 and EU MDR/IVDR requirements.

• Professional proficiency in written and spoken English.

It would be an advantage if you also have experience with:

• FDA regulatory requirements, including 21 CFR Part 820 and QMSR.

• Analytical reagent development and manufacturing.

About Rarity Bioscience

Our superRCA® technology delivers unmatched sensitivity for detecting low-frequency mutations - enabling deeper insights into disease biology and earlier detection of relapse. A growing portfolio of superRCA kits is already in the hands of researchers and clinicians, with more on the way.

We are about 30 people in Uppsala, working across functions without unnecessary layers. The culture is open, direct and prestige-free. Joining us means becoming part of a mission-driven team working to advance precision medicine through pioneering genetic analysis technologies, with the opportunity to make an impact on patients, healthcare and the future of molecular diagnostics.