Hands-on Regulatory Affairs Expert

Sunmedic AB; Vellinge kommun; Hybrid; SEK 550,000 - 850,000; Full time

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.

Skills

Regulatory affairs

EU MDR

ISO 13485

Technical documentation

Audits & inspections

Education

Life sciences / Engineering degree

Job description

Sunmedic is a medical device company focused on developing safe and effective products. We are looking for a hands-on Regulatory Affairs Expert who can take ownership of technical documentation, ensure regulatory compliance, and work closely with quality and development teams.

What you will do

• Prepare, maintain, and update technical files and regulatory documentation in line with EU MDR and other applicable regulations.
• Handle regulatory submissions (EU MDR) and manage lifecycle activities including updates and variations.
• Support and maintain the quality management system (ISO 13485), including quality control documentation and records.
• Review and assess design changes, labeling updates, and material changes for regulatory impact.
• Collaborate with Quality Assurance and R&D teams to ensure technical documentation is complete, accurate, and audit-ready.
• Prepare for and support audits and inspections by notified bodies and competent authorities.
• Contribute to post-market surveillance activities and the preparation of related reports (e.g., PMCF, PSUR).
• Monitor regulatory updates and implement necessary changes in technical files and quality documentation.

Who you are

• A practical and detail-oriented regulatory professional who enjoys working directly with technical files and documentation.
• Comfortable working in a fast-paced environment where you need to deliver concrete regulatory outputs.
• Proactive in identifying compliance gaps and implementing practical solutions.
• Clear communicator who can work effectively with Quality, R&D, and external auditors.

What you have

• Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related field.
• At least 2 years of ,hands-on regulatory affairs experience, in the medical device industry.
• Solid experience preparing and maintaining, technical files, and working within a quality management system (ISO 13485).
• Good knowledge of EU MDR requirements and regulatory submissions.
• Strong organizational skills and attention to detail when managing documentation and multiple tasks.
• Proficiency in English (written and spoken).

Nice to have:

• Experience with post-market surveillance and clinical evaluation reports.
• Familiarity with US FDA 510(k) or UK MDR submissions.
• Previous involvement in audits or inspections.

What we offer

• Competitive salary and benefits.
• Flexible working arrangements.
• The opportunity to work closely with product development and quality teams on real regulatory deliverables.