Regulatory Affairs Specialist - MedTech (f/m/x)

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

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

• Understanding of embedded medical device solutions
• Knowledge of IEC 62304
• Regulatory experience with EU MDR Class II or Class III devices

Job no. JOB-Q8LH2

Sii ensures that all hiring decisions are made solely on the basis of qualifications and competence. We are committed to equal and fair treatment of all, regardless of legally protected characteristics. At Sii, we promote a diverse and inclusive work environment, in full compliance with applicable anti-discrimination laws.

Benefits For You

• Solid financial situation
• Many experts you can learn from
• Contracts with the biggest brands
• Refferals program
• Mentoring program
• 14 authentic core values
• Inclusive culture based on dialogue
• Regular integration events and trips
• Passion Sponsorship Program
• Open and accessible management team
• Profit sharing
• Welcome packs & occasional gifts