Compliance manažer / Manažer pro dodržovaní předpisů

Job Description: Compliance Manager

Location: Litovel, Czechia

Company: Confitex Technology
Reports to: Operations Manager – E.U.
Job Level: Senior
Employment Type: Full-Time, On-Site

Role Summary

• Confitex Innovation Technology seeks a detail-oriented, experienced Compliance Manager for our manufacturing facility in Litovel, Czechia.
• The ideal candidate will ensure full regulatory compliance with applicable standards for medical devices such as ISO 13485, MDSAP, MDR, CE, Oeko-Tex Standard 100, STeP by Oeko-Tex and other relevant industry certifications.
• This is a senior role with critical responsibilities tied to product safety, quality assurance, and international compliance.

Key Responsibilities

• Ensure ongoing compliance with ISO 13485, MDSAP, MDR, CE, Oeko-Tex Standard 100, STeP by Oeko-Tex, and other related regulatory frameworks.
• Ensure compliance with local authorities including fire safety and health standards
• Develop, implement, and manage quality and compliance programs across manufacturing processes.
• Conduct internal and external audits, develop CAPAs, and drive process improvements.
• Coordinate with certification bodies and regulatory agencies as needed.
• Train staff on compliance procedures and quality standards.
• Monitor and report key compliance metrics to senior leadership.
• Support product and process documentation to meet market regulations.
• Collaborate across departments to drive a culture of quality and compliance.

Qualifications and Requirements

• Minimum 3-5 years experience in medical devices class 1 compliance
• Experience in ISO 13485, MDSAP, MDR, CE, Oeko-Tex Standard 100, STeP by Oeko-Tex, or other relevant compliance programs
• Strong knowledge of quality systems, audits, and regulatory frameworks.
• Fluent in Czech and English; other language proficiency is an advantage.
• Excellent communication, organizational and analytical skills.
• Ability to work independently and as part of a team.

Salary and Benefits

The role offers a competitive annual gross salary in the range of CZK 70 000 – CZK 100 000 per month depending on experience. Benefits include:

• Opportunities for professional growth and certification support
• 20 days paid annual leave, will be increased to 25 days after 2-3 years
• Participation in industry conferences and trade shows
• Standard Czech employee benefits (meal vouchers, health care contributions and other)