Regulatory Affairs Specialist – Medical Devices (EU/US)

Sii Poland; Stockholms kommun; On-site; SEK 650,000 - 900,000; Full time

Job summary

Sii is seeking a Regulatory Affairs Specialist to join our Quality & Regulatory Affairs team in Stockholm. You will ensure that medical devices comply with global regulatory requirements and work with Product & Development, QA, and Operations to streamline processes.

You will drive regulatory activities across EU and US markets, maintain technical files per EU MDR, support audits, and monitor regulatory developments to keep the organization compliant and competitive.

Qualifications

• Bachelor’s degree in Regulatory Affairs, Life Sciences, or a related discipline.
• At least 5 years of regulatory affairs experience within the medical device industry.
• Practical knowledge of EU MDR Class I and FDA QSR requirements.
• Experience managing technical documentation and regulatory records.
• Familiarity with QMS, document control, and regulatory management systems.
• Experience supporting regulatory inspections or audits.
• Strong coordination, communication, and stakeholder management skills.
• Ability to present regulatory matters clearly to technical and non-technical audiences.

Responsibilities

• Improve regulatory workflows with Product Development, Quality, and Operations.
• Prepare for regulatory audits and coordinate with auditors.
• Evaluate device classifications for different markets.
• Create, review, and maintain technical files for EU MDR.
• Manage declarations of conformity and ensure supporting docs align.
• Coordinate product registrations and device listings with authorities.
• Support market access activities in the EU and the US.
• Track regulatory developments and communicate impacts across the org.

Skills

Regulatory affairs

Cross-functional coordination

Regulatory communication

Audits & inspections

Documentation management

QMS familiarity

Stakeholder management

Presenting to audiences

Education

Bachelor's degree in Regulatory Affairs/Life Sciences

Job description

Sii is seeking a Regulatory Affairs Specialist to join our Quality & Regulatory Affairs team in Stockholm. You will ensure that medical devices comply with global regulatory requirements and work with Product & Development, QA, and Operations to streamline processes.

You will drive regulatory activities across EU and US markets, maintain technical files per EU MDR, support audits, and monitor regulatory developments to keep the organization compliant and competitive.