Global Regulatory Affairs Specialist - Medical Devices

Celsus Engineering AB; Sweden; Hybrid; SEK 45,000 - 70,000; Full time

Job summary

Celsus Engineering AB, based in Sweden, is seeking a Global Regulatory Specialist to join its Quality & Regulatory Affairs team. The successful candidate will help ensure compliance with global regulatory standards for medical devices, working in a hybrid role with some onsite presence in Stockholm.

The ideal candidate has a bachelor's degree in a relevant field and at least 5 years of experience in medical device regulatory affairs. Strong skills in problem-solving, communication, and organization are essential.

Qualifications

• 5+ years of experience in medical device regulatory affairs, with EU MDR and FDA QSR experience.
• Hands-on experience with regulatory compliance, technical documentation, and audits.
• Strong proficiency in spoken and written English.

Responsibilities

• Streamline regulatory processes and set a roadmap in collaboration with teams.
• Coordinate internal and external audits to support audit readiness.
• Review device classifications and update technical documents for compliance.

Skills

Detail-oriented

Problem-solving

Communication skills

Analytical skills

Organization skills

Education

Bachelor's degree in Regulatory Affairs, Life Sciences, Electrical-Electronics or a related field

Tools

Regulatory systems

Document control tools

QMS platforms

Job description

Celsus Engineering AB, based in Sweden, is seeking a Global Regulatory Specialist to join its Quality & Regulatory Affairs team. The successful candidate will help ensure compliance with global regulatory standards for medical devices, working in a hybrid role with some onsite presence in Stockholm.

The ideal candidate has a bachelor's degree in a relevant field and at least 5 years of experience in medical device regulatory affairs. Strong skills in problem-solving, communication, and organization are essential.