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Senior Quality and Regulatory Affairs Specialist page is loaded

Senior Quality and Regulatory Affairs Specialist

Apply locations POL - Warsaw time type Full time posted on Posted 30+ Days Ago job requisition id R79316

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?

• Coordinate product handling activities including value-added services between the legal manufacturer and the third-party logistics provider with a focus on quality and perform the control of the products where required.
• Coordinate the quality hold/ field action/return/ complaint handling processes, ensure the correct disposition of the products 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.
• Support the maintenance of Quality Management System for relevant site(s) and provide input to the quality processes and procedures to ensure compliance, efficiency and clarity.
• Support the Quality and Regulatory activities across the EU S+N Commercial sites.
• Represent and support Quality and Regulatory Affairs (RA) processes during audits by Certification Bodies, Notified Bodies, and Regulatory Inspectors.
• 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.

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 3PL facility in Blonie, Poland with the requirement to be on-site.

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.

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

Work/Life Balance: paid volunteering hours, flexible approach.

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.

Extra Perks: referral bonus, recognition program, mentoring program.

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Warszawa - Oferty pracy w okolicznych lokalizacjach