Global Regulatory Specialist (Medical Devices)

Location: Hybrid, with 1–3 days per week onsite at the Stockholm office in Östermalm; occasional international travel of 10–20% may be required.

Company

Develops assistive communication solutions and mounting systems for people with disabilities.

What you will do

• Streamline regulatory processes and develop roadmaps with Product & Development, QA, and Operations.
• Coordinate with internal and external auditors to maintain audit readiness.
• Review device classifications and regulatory challenges across markets.
• Maintain technical documentation, Annex II and III files, and declarations of conformity.
• Coordinate FDA registrations and device listings with Authorized Representatives and Importers/Distributors.
• Support product registrations, market access, and monitoring of regulatory changes.

Requirements

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Electrical-Electronics, or a related field.
• At least 5 years of experience in medical device regulatory affairs.
• Hands-on experience with EU MDR Class I and FDA QSR.
• Experience with regulatory systems, document control tools, QMS platforms, technical documentation, and regulatory compliance audits.
• Strong organization, coordination, communication, analytical, and problem-solving skills.
• Proficiency in spoken and written English is required.

Nice to have

• Familiarity with embedded systems and IEC 62304.
• Experience with EU MDR Class II/III.
• Additional language skills, such as German.

Culture & Benefits

• Hybrid work arrangement with flexibility outside of onsite requirements.
• International collaboration and occasional travel.
• Ongoing learning and development opportunities.
• Collaborative, cross-functional, and inclusive work environment.
• Focus on equality of opportunity, dignity, and diversity.