Regulatory Affairs Senior Specialist (IVD)

Location: On-site in Solna, Stockholm, Sweden

Company

Cepheid is a hirify.global operating company that develops fast, accurate molecular diagnostic systems and tests for global healthcare markets.

What you will do

• Lead regulatory impact assessments for analytical, manufacturing, labeling, packaging, and supplier changes.
• Prepare, submit, and maintain regulatory submissions and technical documentation for EU IVDR and international pathways.
• Manage regulatory change control activities and interactions with Notified Bodies and global regulatory authorities.
• Partner with manufacturing, operations, supply chain, product management, and commercial quality and regulatory teams on product lifecycle management and compliance strategies.
• Monitor emerging requirements, provide regulatory intelligence, and deliver regulatory guidance and training.
• Lead regulatory compliance activities during audits, post-market surveillance, nonconformances, CAPAs, and complaint investigations.

Requirements

• Bachelor’s degree or higher in Life Sciences, Biotechnology, Biomedical Sciences, Chemistry, Regulatory Affairs, Engineering, or a related scientific discipline.
• Several years of experience in Regulatory Affairs, Quality Assurance, or a related regulated function within IVD, medical device, biotechnology, or life sciences.
• Experience preparing and maintaining technical documentation and submissions under EU IVDR, IVDD, MDR, FDA, or other global regulatory frameworks.
• Experience performing regulatory assessments and supporting change management throughout the product lifecycle.
• Experience collaborating with cross-functional stakeholders, regulatory authorities, Notified Bodies, or international agencies.
• Fluency in English and Swedish.

Nice to have

• Experience with WHO Prequalification, Emergency Use Listing, or other global public health regulatory programs.
• Experience with registrations in Africa, the Middle East, Asia-Pacific, or Latin America.
• Regulatory Affairs Certification, an MSc or PhD, or equivalent advanced regulatory training.

Culture & Benefits

• On-site role within the Regulatory Affairs organization in Solna.
• Opportunity to contribute to products addressing complex global health challenges.
• Comprehensive benefits, including healthcare programs and paid time off.
• Domestic and international travel approximately 2–3 times per year.