Application checklist
Review your application before submitting
A quick checklist to help candidates submit a clearer, more complete application.
Read resourceSwedenFull TimeTechnical and Medical Sales Professionals (excluding ICT)
Regulatory Affairs Specialist - MedTech (f/m/x)
Sii Sweden | Stockholm, Stockholm County, Sweden | Salary not specified
Source: JobsPipe
Required Skills
communication
Role snapshot
- Work model
- On-site
- Language
- Not specified
- Experience
- Not specified
- Posted
- Posted 1 day ago
- Application deadline
- 2026-10-31
What you'll do
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
Work resources