Medical Device QA & Regulatory Affairs Pro

Air Liquide; Bromma; On-site; SEK 700,000 - 900,000; Full time

Job summary

Nordic Infucare, now part of Air Liquide, seeks a Medical Device Quality Assurance & Regulatory Affairs Specialist in Sweden to ensure MDR/IVDR compliance and maintain the QMS. You will review materials, audits, and liaison with authorities, with a split focus 60% QA and 40% RA.

The ideal candidate holds a Bachelor in Pharmaceutical Science or equivalent with 3–5 years in life science and experience with MDR/IVDR and ISO 13485. Some travel for external audits may be required.

Qualifications

• Bachelor in Pharmaceutical Science or equivalent.
• 3–5 years experience in life science.
• Experience with MDR 2017/745 and IVDR 2017/746, and ISO 13485.

Responsibilities

• Act as main liaison for regulatory affairs with authorities.
• Maintain and improve QMS procedures and CAPA program.
• Review marketing materials, product labels, and IFUs for compliance.
• Audit outsourced distribution partners and host MDR audits.

Skills

Regulatory affairs

Quality Assurance

QMS

CAPA

Audits

Regulatory liaison

Education

Bachelor of Pharmaceutical Science

Tools

ISO 13485

Job description

Nordic Infucare, now part of Air Liquide, seeks a Medical Device Quality Assurance & Regulatory Affairs Specialist in Sweden to ensure MDR/IVDR compliance and maintain the QMS. You will review materials, audits, and liaison with authorities, with a split focus 60% QA and 40% RA.

The ideal candidate holds a Bachelor in Pharmaceutical Science or equivalent with 3–5 years in life science and experience with MDR/IVDR and ISO 13485. Some travel for external audits may be required.