Senior Biocompatibility Lead - Medical Devices

Molnlycke Health Care; Göteborgs kommun; Hybrid; SEK 900,000 - 1,100,000; Full time

Job summary

Mölnlycke in Gothenburg is expanding its Biocompatibility team with a Senior Biocompatibility Specialist to strengthen our expertise in Biological Safety. The role focuses on leading evaluations of medical devices, aligning with global regulatory requirements, and driving risk interpretation and safety assessments across a global portfolio.

You will develop procedures, oversee testing with internal and external partners, mentor colleagues, and be a key SME supporting projects and regulatory

Qualifications

• Must-have: degree in engineering, chemistry, life sciences or equivalent.
• Typically 8+ years experience in biocompatibility, toxicology or related field.
• Experience working with medical devices and knowledge of regulatory requirements.

Responsibilities

• Lead, plan, perform, and review biological evaluations of medical devices per global regulatory requirements.
• Develop and implement biocompatibility procedures, guidelines, and ways of working.
• Coordinate and oversee biocompatibility testing with internal and external partners.
• Act as Subject Matter Expert, supporting projects, regulatory activities and decision-making.
• Interpret biological risk from scientific and toxicological perspectives to support safety assessments.
• Build external networks and represent Mölnlycke in scientific forums.
• Contribute to team growth through coaching and knowledge sharing.

Skills

Biocompatibility

Toxicology

Regulatory knowledge

Scientific communication

Education

Master’s or Bachelor’s degree in engineering, chemistry, life sciences

Job description

Mölnlycke in Gothenburg is expanding its Biocompatibility team with a Senior Biocompatibility Specialist to strengthen our expertise in Biological Safety. The role focuses on leading evaluations of medical devices, aligning with global regulatory requirements, and driving risk interpretation and safety assessments across a global portfolio.

You will develop procedures, oversee testing with internal and external partners, mentor colleagues, and be a key SME supporting projects and regulatory