Senior QA & Regulatory Compliance Lead (Remote)

Nordberg Medical; Stockholms kommun; Hybrid; SEK 600,000 - 800,000; Full time

Benefits offered by this job

Flexible working schedule

Career development opportunities

Inclusive team environment

Job summary

Nordberg Medical is seeking a Senior Quality Assurance Specialist to ensure compliance with quality and regulatory requirements for its flagship product, JULÄINE, a Class III medical device. The position involves collaboration with cross-functional teams to drive quality documentation submissions and ensure organizational quality standards.

You will be a key member of the global Quality Assurance team, focusing on continuous improvement and maintaining regulatory compliance across various regions. This hybrid or remote role requires legal eligibility to work in Sweden.

Qualifications

• Bachelor’s degree in life sciences, engineering, biomedical engineering, or pharmacy.
• Experience in Quality Assurance within the medical device industry.
• Knowledge of Quality Management Systems requirements, preferably ISO 13485.

Responsibilities

• Support the development and maintenance of the QMS.
• Ensure quality processes are effectively established and monitored.
• Drive the creation and harmonization of quality procedures.
• Oversee change control activities and ensure compliance.
• Coordinate CAPA processes and ensure timely follow-up.
• Prepare quality inputs for management reviews.

Skills

Quality Management Systems

Regulatory compliance

ISO 13485

Analytical skills

Cross-functional collaboration

Education

Bachelor’s degree in life sciences or related field

Job description

Nordberg Medical is seeking a Senior Quality Assurance Specialist to ensure compliance with quality and regulatory requirements for its flagship product, JULÄINE, a Class III medical device. The position involves collaboration with cross-functional teams to drive quality documentation submissions and ensure organizational quality standards.

You will be a key member of the global Quality Assurance team, focusing on continuous improvement and maintaining regulatory compliance across various regions. This hybrid or remote role requires legal eligibility to work in Sweden.