Global Regulatory Vigilance & Submissions Specialist

RaySearch Laboratories; Stockholms kommun; On-site; SEK 550,000 - 750,000; Full time

Benefits offered by this job

In-house gym

Yoga classes

Social events

Lunch buffet

Daily fika

Rooftop terrace

Competitive compensation

Job summary

RaySearch Laboratories in Stockholm is seeking a Regulatory Affairs Support Specialist to own vigilance activities and back regulatory submissions for global markets.

You will collaborate across QA and Regulatory Affairs, Service and Development, ensuring compliant post‑market surveillance and timely regulatory deliverables.

The role suits a few years of medical device regulatory experience, with EU MDR and ISO 13485 familiarity, and strong English communication.

Qualifications

• You have a university degree in Life Sciences, Engineering, Biomedical Engineering or a related field.
• You have 2 years of experience in regulatory affairs within the medical device industry.
• You have experience with EU MDR requirements and ISO 13485.

Responsibilities

• Own and coordinate regulatory vigilance activities.
• Assess complaints and incidents for reportability under applicable regulations.
• Prepare, submit and follow up vigilance reports with competent authorities and notified bodies.
• Support post-market surveillance activities and regulatory compliance efforts.
• Support regulatory submissions and registrations in global markets.
• Maintain and update regulatory documentation and records.
• Monitor changes in regulatory requirements.
• Collaborate with internal stakeholders to ensure timely and compliant regulatory deliverables.
• Contribute to the continuous improvement of regulatory processes and procedures.

Skills

Regulatory affairs

Vigilance

Post-market surveillance

Regulatory submissions

EU MDR

ISO 13485

English communication

Cross-functional collaboration

Attention to detail

Education

University degree in Life Sciences, Engineering, Biomedical Engineering

Job description

RaySearch Laboratories in Stockholm is seeking a Regulatory Affairs Support Specialist to own vigilance activities and back regulatory submissions for global markets.

You will collaborate across QA and Regulatory Affairs, Service and Development, ensuring compliant post‑market surveillance and timely regulatory deliverables.

The role suits a few years of medical device regulatory experience, with EU MDR and ISO 13485 familiarity, and strong English communication.