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Senior Quality and Regulatory Affairs Specialist, Warsaw

Client: Smith+Nephew

Location: Warsaw, Poland

Job Category: Other

EU work permit required: Yes

Job Reference: b95c2bd88f5f

Job Views: 5

Posted: 23.01.2025

Expiry Date: 09.03.2025

Job Description:

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.

At Smith+Nephew we are looking for: Senior Quality and Regulatory Affairs Specialist

What will you be doing?

• Maintain and manage the Quality Management System (QMS) for relevant sites to ensure compliance and effectiveness
• Develop, review, and enhance quality processes and procedures for clarity, compliance, and operational efficiency
• Represent and support Quality and Regulatory Affairs (RA) processes during audits by Certification Bodies, Notified Bodies, and Regulatory Inspectors
• Oversee Competent Authority reporting related to Field Safety Corrective Actions (FSCAs) and ensure timely communication
• Administer Corrective and Preventative Action (CAPA) and Non-conformance (NC) systems, including logging, investigation support, action tracking, and progress monitoring
• Report monthly on quality and regulatory metrics to track and enhance compliance and performance
• Support complaint handling, product holds, recalls, and supplier audits, ensuring smooth coordination and alignment with regulatory requirements
• Support on the management of third-party manufacturers (POLO, PORO and POGO) and service providers with regards to performing supplier audits, managing supplier databases to include supplier documentation and data to support business activities

What will you need to be successful?

• Education: Bachelor of Science degree with solid knowledge of EU Medical Device Regulation (2017/745), related laws, and ISO 9001:2015
• Licenses/Certifications: Accredited Quality certificate, ASQ certification, or equivalent is preferred
• Experience: 2–4 years of experience in inspection activities or similar roles within a regulated industry under a Quality Management System
• Competencies: Strong understanding of Good Distribution Practices, attention to non-conformities, and ability to assess products against specifications
• Skills: Excellent documentation, communication (written and verbal), and teamwork skills, with the ability to work independently as needed
• Responsibilities: Manage critical elements of the quality system for EU commercial sites, ensuring compliance and providing performance summaries
• Health & Safety: Apply and uphold high occupational Health & Safety standards in accordance with company policies

Location: Role will be primarily located at S+N Warsaw, Poland. It will be required to travel to 3PL location in Warsaw.

You. Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about our Employee Inclusion Groups on our website

Your Future: annual bonus, life insurance, company stock saving plan

Your Wellbeing: private health care with dental care package, multisport card/my benefit platform

Flexibility: possibility of working in hybrid model

Training: Hands-On, Team-Customized, subsidies for language classes, certifications and postgraduate studies

Warszawa - Oferty pracy w okolicznych lokalizacjach