Regulatory Affairs Specialist - MedTech (f/m/x)
Company: Sii Sweden
- Location: Stockholm, Sweden
- Seniority: Senior
- Employment type: Full-time
- Posted: 11 days ago
- Offer language: English
Job description
We are looking for a Regulatory Affairs Specialist to join our Quality & Regulatory Affairs team in Stockholm. In this role, you will ensure that the medical devices comply with global regulatory requirements. You will work collaboratively with cross-functional teams, including Product & Development, QA, and Operations, to streamline regulatory processes and support audit readiness. If you enjoy solving complex regulatory challenges and thrive in a dynamic environment, this opportunity may be the right fit for you.
Your tasks
- Improve regulatory workflows and establish clear plans with Product Development, Quality, and Operations
- Prepare the organization for regulatory audits and coordinate with internal and external auditors
- Evaluate device classifications and resolve regulatory issues in different markets
- Create, review, and maintain technical files in line with EU MDR requirements
- Manage declarations of conformity and ensure consistency with supporting documentation
- Coordinate product registrations and device listings with relevant authorities and market representatives
- Support market access activities in the EU and the US
- Track regulatory developments and communicate their impact across the organization
Requirements
- 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
Nice-to-have requirements
- Understanding of embedded medical device solutions
- Knowledge of IEC 62304
- Regulatory experience with EU MDR Class II or Class III devices
