Hands-On EU MDR Regulatory Lead — Medical Devices

Sunmedic AB

Vellinge kommun

Hybrid

SEK 550,000 - 850,000

Full time

14 days+

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Job summary

Sunmedic AB in Sweden is seeking a hands-on Regulatory Affairs Expert to own technical documentation, ensure regulatory compliance, and collaborate with Quality and R&D teams on real regulatory deliverables. You will maintain technical files, manage EU MDR submissions, support ISO 13485 QMS, and contribute to post-market surveillance and audits with notified bodies and authorities.

The role requires 2+ years in medical device regulatory affairs, a Life Sciences or Engineering degree, and strong

Qualifications

Bachelor’s or Master’s degree in Life Sciences, Engineering, or related field.
At least 2 years of hands-on regulatory affairs experience in the medical device industry.
Experience maintaining technical files and working within ISO 13485 QMS.
Good knowledge of EU MDR requirements and regulatory submissions.

Responsibilities

Prepare and maintain technical files per EU MDR.
Handle regulatory submissions and lifecycle activities.
Support ISO 13485 QMS documentation and records.
Assess regulatory impact of design changes, labeling updates, and material changes.
Collaborate with QA and R&D to ensure audit readiness.
Assist audits by notified bodies and competent authorities.
Contribute to post-market surveillance and related reports.