Quality & Regulatory Manager — SaMD, Remote/Hybrid

Star; Wrocław; Hybrid; PLN 180,000 - 240,000; Full time

Benefits offered by this job

Flexible working (hybrid/remote)

Generous time off policies

Rewards and compensation package

Mentorship and training

Job summary

Star is seeking a Quality Manager with a passion for consulting to join our Quality and Regulatory Affairs team and gain exposure to our diverse projects. You will establish and manage ISO13485 compliant QMS for clients and act as a regulatory liaison with notified bodies and market regulators.

You will work in a small team of regulatory enthusiasts, coordinating QMS activities and supporting engineering to deliver safe medical devices, while shaping regulatory strategies for mostly software as

Qualifications

• 3+ years in quality management (ISO 13485 or ISO 9001).
• Experience as quality manager or regulatory affairs professional.
• Strong knowledge of ISO 13485 and ISO 14971.
• Understanding of SaMD lifecycle, documentation and validation.
• Knowledge of AI regulatory frameworks and ethics.
• Business fluency in English (speaking and writing).
• Excellent communication and leadership skills.

Responsibilities

• Establish, implement and manage ISO13485 QMS for clients.
• Act as management representative with notified bodies and regulators.
• Coordinate activities related to the QMS.
• Support engineering and service teams in delivering safe medical devices.
• Define and execute regulatory strategies for SaMD products.
• Support product teams in preparing technical documentation for market approvals.
• Educate and raise awareness about the QMS within the organization.
• Conduct audits and support quality goal achievement.
• Continuously improve the QMS in the organization.

Skills

Quality management

Regulatory affairs

ISO 13485

Quality systems

English proficiency

Job description

Star is seeking a Quality Manager with a passion for consulting to join our Quality and Regulatory Affairs team and gain exposure to our diverse projects. You will establish and manage ISO13485 compliant QMS for clients and act as a regulatory liaison with notified bodies and market regulators.

You will work in a small team of regulatory enthusiasts, coordinating QMS activities and supporting engineering to deliver safe medical devices, while shaping regulatory strategies for mostly software as