Quality & Regulatory Affairs (QRA) Specialist (FT - Remote Europe)

Ikerian; United Kingdom; Remote; GBP 45,000 - 60,000; Full time

Job summary

A medical device software company is seeking a QRA Specialist to enhance its quality and regulatory operations team. This role involves ensuring compliance with international medical device regulations and managing documentation for regulatory submissions. The ideal candidate will have a degree in Regulatory Affairs and significant experience with US and EU regulations. A competitive salary and flexibility with a remote-first setup are offered.

Benefits

Competitive salary and benefits

Remote-first setup

Career growth opportunities

Inclusive culture

Qualifications

• 3+ years of experience in medical device quality and regulatory affairs.
• Deep knowledge of ISO 13485, EU MDR, IEC 62304, ISO 14971, and FDA 21 CFR Part 820.
• Proven experience with EU MDR and FDA submissions.

Responsibilities

• Ensure product compliance with FDA, EU MDR, ISO 13485, and other standards.
• Review internal procedures for compliance with global regulations.
• Support preparation of technical documentation for CE Marking and FDA submissions.

Skills

Regulatory Affairs expertise

Project management

Cross-functional collaboration

Communication skills

Education

University degree in Regulatory Affairs or related field

Job description

Quality & Regulatory Affairs (QRA) Specialist (FT - Remote Europe)

About Us
Ikerian AG (formerly RetinAI Medical) is a fast-growing medical device software company headquartered in Bern, Switzerland. Our mission is to enable the right decisions sooner in healthcare, through transformative AI & data management solutions for disease screening and monitoring. Join our diverse team of entrepreneurs, developers, researchers, and commercial experts who are collectively shaping the future of healthcare.

Job Description
We are looking for a meticulous and driven QRA Specialist to strengthen our quality and regulatory operations team. This role is ideal for a highly motivated professional with a background in SaMD/MDSW regulations (EU & US), who thrives in a collaborative, fast-paced environment. The QRA Specialist will contribute to regulatory strategies, maintain our QMS, and ensure compliance with international medical device regulations and standards.

Responsibilities

• Ensure product compliance with FDA, EU MDR, ISO 13485, IEC 62304, and other applicable standards
• Review internal procedures for compliance with global regulations
• Support preparation of technical documentation for CE Marking, UKCA, and FDA submissions
• Prepare and submit FDA 510(k), DeNovo, Breakthrough and Pre-Submission documentation, managing all aspects of CDRH and other related regulatory filings
• Oversee regulatory compliance activities including HIPAA, and future certifications such as MDSAP
• Ensure compliance with FDA QSR - 21 CFR Part 820, ISO 13485 QMS, ISO 14971 risk management, and MDR requirements
• Manage internal and external audits, maintaining readiness and documentation compliance
• Coordinate cross-functional teams, facilitating effective communication and efficient project execution
• Utilize project management methodologies to ensure timely completion of regulatory related initiatives
• Maintain detailed documentation and oversee continuous improvement processes to enhance operational efficiency and compliance

Qualifications

• University degree in Regulatory Affairs or related field
• 3+ years of experience in medical device quality and regulatory affairs
• Deep knowledge of ISO 13485, EU MDR, IEC 62304, ISO 14971, and FDA 21 CFR Part 820
• Proven experience with EU MDR and FDA submissions
• Experience with audits (Notified Bodies & FDA)
• Strong project management and cross-functional collaboration skills
• Excellent communication in English (spoken & written)
• Ability to travel occasionally
• If based in Switzerland, Tuesday presence in the office in Bern is obligatory
• Certification in Regulatory Affairs (RAC) is a plus
• Prior experience managing MDSAP certification processes is a plus

Benefits

• Opportunity to be part of a high-impact team shaping the future of healthcare
• Competitive salary and benefits
• Remote-first setup with flexibility and work-life balance
• Career growth and development in an international company
• Inclusive and collaborative culture
• Travel opportunities to HQ in Switzerland for audits, workshops, and team events
• Provision of hardware/software for efficient remote work

Seniority level

• Associate

Employment type

• Full-time

Job function

• Quality Assurance

Industries

• IT Services and IT Consulting

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