Entry-Level QA & Regulatory Affairs Associate

BD; Województwo mazowieckie; On-site; PLN 82,000 - 125,000; Full time

Job summary

BD in Poland is seeking a Junior Quality & Regulatory Affairs Specialist on a fixed-term 2-year contract. The role combines quality assurance and regulatory affairs in an international healthcare environment, with responsibilities spanning audit follow-ups, CAPAs, and documentation control, plus regulatory database maintenance.

The ideal candidate has a Bachelor’s degree (or in progress) in Life Sciences or related fields, strong English, and a detail-oriented, proactive mindset.

Qualifications

• Good written and spoken English.
• Strong computer skills and confidence with Microsoft Office applications.
• Excellent attention to detail and organizational skills.
• Ability to manage multiple tasks and prioritize effectively.
• Strong sense of responsibility and ownership.
• Positive attitude and willingness to learn.
• Ability to work independently and as part of a team.

Responsibilities

• Tracking and following up on audit actions and quality improvement initiatives.
• Supporting CAPAs (Corrective and Preventive Actions), Nonconformances (NCs), and Planned Deviations.
• Assisting with quality metrics and reporting.
• Supporting document updates and document control activities.
• Contributing to customer quality questionnaires and compliance requests.
• Assisting with training records and quality system administration.
• Maintaining quality records and ensuring timely completion of assigned tasks.
• Supporting continuous improvement initiatives and quality projects.
• Maintaining and administering the released product database in Regulatory Affairs.
• Keeping product records accurate, adding new products and updating obsolete ones.
• Uploading, replacing, and maintaining regulatory certificates and supporting documentation.
• Ensuring regulatory records reflect current approval and certification status.
• Performing routine reviews and quality checks of database content.
• Resolving data discrepancies and supporting data-cleanup activities.
• Assisting with regulatory documentation and record management.
• Supporting other entry-level regulatory and administrative activities as needed.

Skills

English proficiency

Attention to detail

Organizational skills

Multitasking

Ownership & accountability

Team player

Education

Bachelor's degree in Life Sciences, Engineering, Healthcare, Business, or related field

Job description

BD in Poland is seeking a Junior Quality & Regulatory Affairs Specialist on a fixed-term 2-year contract. The role combines quality assurance and regulatory affairs in an international healthcare environment, with responsibilities spanning audit follow-ups, CAPAs, and documentation control, plus regulatory database maintenance.

The ideal candidate has a Bachelor’s degree (or in progress) in Life Sciences or related fields, strong English, and a detail-oriented, proactive mindset.