Global Regulatory Specialist for a MedTech company in Stockholm!

About the role

As a Global Regulatory Specialist, you will join our client's global Quality & Regulatory Affairs function and play a key role in ensuring that medical devices and mounting systems comply with regulatory requirements across international markets. You will become part of a central regulatory team based in Stockholm, supporting a global organization that operates in more than 80 countries and holds a market-leading position within assistive communication solutions. The role combines operational responsibilities with strategic influence. While maintaining existing regulatory processes, you will also support the organization by interpreting regulatory changes, providing expert guidance, and ensuring continued market access for the company's products.

Responsibilities

• Maintain and improve technical documentation, including Annex II & III documentation and EU Declarations of Conformity.
• Coordinate product registrations and device listings with regulatory authorities, including the FDA, Authorized Representatives, and distributors.
• Support regulatory compliance activities related to EU MDR Class I products and FDA 510(k)-exempt Class II devices.
• Review device classifications and assess regulatory implications across global markets.
• Coordinate internal and external audits and support audit readiness activities.
• Monitor changes in global regulatory requirements and communicate their impact throughout the organization.
• Collaborate closely with Product Development, Quality, Operations, and other cross-functional teams to ensure regulatory compliance throughout the product lifecycle.
• This is a highly collaborative global role with frequent interaction with colleagues across Europe, North America, Asia, and Australia. While most collaboration takes place virtually, occasional international travel may occur, primarily within Europe.
• We are looking for someone whoHolds a Bachelor's degree in Regulatory Affairs, Life Sciences, Electrical Engineering, Electronics, or a related field.
• Has at least five years of experience working within Medical Device Regulatory Affairs.
• Has solid hands-on experience with EU MDR (Class I) and FDA Quality System Regulations (QSR).
• Has experience working with regulatory systems, document management tools, QMS platforms, technical documentation, and regulatory audits.
• Is comfortable interpreting complex regulatory requirements and translating them into practical guidance for different stakeholders.
• Communicates fluently in English, both verbally and in writing.
• Experience working with embedded systems, IEC 62304, EU MDR Class II/III products, or additional languages such as German is considered highly meritorious.
• We believe you areOur client place great emphasis on personal qualities, as success in this role depends on your ability to work collaboratively across a global organization while maintaining high regulatory standards.
• You are confident in communicating regulatory requirements and able to influence others through facts and expertise. Rather than seeking a managerial position, you enjoy being the subject matter expert that colleagues rely on when navigating regulatory challenges.
• Curiosity and a willingness to continuously learn are highly valued, as regulations continue to evolve across global markets.
• About the partner company
• Our client is a global MedTech company headquartered in Stockholm and a world leader within assistive communication solutions. Every day, their products empower people with disabilities to communicate, connect with others, and live more independent lives.
• The Quality & Regulatory Affairs function is centrally located in Stockholm and collaborates closely with colleagues across Europe, North America, Asia, and Australia. You will join an experienced international organization where expertise, collaboration, and continuous learning are highly valued.
• About the employment
• This is a consulting assignment with employment through OIO. The assignment is expected to run for 6-12 months, with excellent opportunities for a permanent position with the client if both parties are satisfied.
• Scope: Full-time
• Start: August 2026 (for the right candidate, some flexibility is available)
• Location: Stockholm, Östermalm (hybrid, 1-3 days per week in the office)
• Working hours:

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