Requirements: English
Company: Demant Polska
Region: Roswek , West Pomeranian Voivodeship
We are looking for a Global Change Control Manager. This is a key role responsible for overseeing the implementation, governance, and continuous improvement of the Change Control Process across the organization. You will ensure that all changes to released medical products and production processes comply with global regulatory requirements, internal Quality Management Systems (QMS), and organizational objectives. Acting as the central point of contact for change control activities, you will drive consistency, efficiency, and compliance across all brands and regions.
Working with us you will receive:
- A full-time contract;
- Opportunities for learning and professional growth tailored to your needs;
- A hybrid work model, combining remote work opportunities with work in an office in Roswek;
- A competitive benefits package (private medical care, insurance, sport card, etc.);
- A Scandinavian work culture built on equality, independence, open dialogue, and work-life balance.
What tasks are waiting for you?
- Establish and improve the change control process in compliance with global regulations (e.g., FDA, ISO 13485, MDR).
- Collaborate with cross-functional teams (R&D, Quality, Regulatory Affairs, Production, Product Management) to ensure process alignment.
- Supervise change request management, ensuring proper documentation, categorization, and compliance.
- Conduct risk and impact assessments, including audits to maintain compliance and drive improvements.
- Lead ECO board meetings, escalate major changes when necessary, and ensure clear communication.
- Develop and provide training on the Change Control Procedure, monitor compliance, and address gaps.
- Identify opportunities for continuous improvement, adopting best practices and staying updated on regulatory trends.
We are looking for someone with:
- A Bachelor''s or Master''s degree in Engineering, Life Sciences, Quality Management, or a related field;
- At least 5 years of experience in change control, quality management, or product lifecycle management in a regulated industry (medical devices, pharmaceuticals, or healthcare technology preferred);
- Hands-on experience with PLM systems (e.g., ARAS, Agile, Windchill) and QMS software;
- Strong knowledge of regulatory compliance (FDA 21 CFR Part 820, ISO 13485, MDR);
- Experience leading cross-functional teams in a global organization.
- Expertise in Engineering Change Management (ECO, ECR, MCO) and root cause analysis (e.g., FMEA, Six Sigma);
- Strong understanding of risk management in medical product development;
- Excellent communication and stakeholder management skills;
- Ability to lead change in a complex global environment while managing competing priorities;
- High attention to detail and a structured approach to problem-solving.
In the position of Global Change Control Manager, you will work closely with Gosia Nowakowska, your direct supervisor.
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