Regulatory Affairs Senior Specialist

The QRC On-market Sustainment team creates the regulatory strategy and assessments for complex post market design changes; interfaces with global regulatory authorities including BSI and WHO; and collaborates cross functionally to assess regulatory risk, define data and submission requirements as a result of design changes. 

As the Regulatory Affairs Senior Specialist is responsible for supporting global regulatory activities for Cepheid's in vitro diagnostic products throughout the product lifecycle. This role drives regulatory compliance by leading regulatory assessments, preparing and maintaining technical documentation, managing regulatory submissions, and supporting interactions with global regulatory authorities and Notified Bodies. The position plays a key role in enabling product registrations, implementation of product changes, and continued market access globally.  

This position reports to the Principal Regulatory Affairs Specialist and is part of the Regulatory Affairs organization, located in Solna, Stockholm, Sweden, and will be an on-site role.  

In this role, you will have the opportunity to: 

• Serve as the RA Lead on Project teams and provide highly complex regulatory impact assessments for analytical, manufacturing, labeling, packaging, and supplier changes to ensure global compliance.  

• Prepare, compile, submit, and maintain regulatory submissions and technical documentation for global markets, including EU IVDR and international regulatory pathways.  

• Manage regulatory change control activities and interactions with Notified Bodies and regulatory authorities.  

• Serve as a key regulatory business partner to manufacturing, operations, supply chain, RA NPD, Global Product Management and the Commercial QRA Center of Excellence to define data requirements, support product lifecycle management, continuous improvement initiatives, and regulatory compliance strategies through use of DBS tools. 

• Monitor emerging regulatory requirements, provide regulatory intelligence, and deliver regulatory guidance and training across the organization; act as regulatory affairs lead for compliance during internal and external audits, post market surveillance, nonconformances, CAPAs and complaint investigations. 

The essential requirements of the job include: 

• 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 the IVD, medical device, biotechnology, or life sciences industry. 

• Experience preparing and maintaining technical documentation and regulatory submissions supporting EU IVDR, IVDD, MDR, FDA, or other global regulatory frameworks. 

• Demonstrated experience performing regulatory assessments and supporting change management processes throughout the product lifecycle. 

• Experience working directly with cross-functional stakeholders and regulatory authorities, Notified Bodies, or international regulatory agencies. 

• Fluency in English and Swedish

It would be a plus if you also possess previous experience in: 

• WHO Prequalification (WHO PQ), Emergency Use Listing (EUL), or other global public health regulatory programs. 

• Regulatory submissions and registrations in Rest of World markets, including Africa, Middle East, Asia-Pacific, or Latin America. 

• Regulatory Affairs Certification (RAC), advanced scientific degree (MSc/PhD), or equivalent advanced regulatory training. 

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel domestically and internationally up to 2-3 times a year

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.