Quality & Regulatory Affairs Specialist (Portuguese market)
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
What You Can Expect
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As a QARA Specialist, you will be part of the EMEA Quality Commercial \& Distribution Team within the Commercial Organization.
You will be responsible for supporting the Quality Assurance \& Regulatory Affairs function of Portugal by:
- ensuring compliance with the requirements of ISO 13485 Quality Management System, appropriate company policies and any other ISO if applicable or required in country (i.e ISO9001, ISO14001, ISO37001 e.t.c).
- ensuring local organization comply with industry specifications, standards and European as also in country regulations (i.e European Medical Device Regulation (EU) 2017/745\).
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Quality Management System (QMS)
- Support implementation, development, maintenance, and improvement of the local QMS (Quality Management System)
- Drive CAPAs and Issue Evaluations
- Participate, provide support and manage quality reviews
- Support with QA/RA standardization of processes
- Work on continuous improvement of our processes
- Be responsible for product registration, notifications, or renewals and/or regulatory clearance in assigned market in accordance with local in\-country regulatory requirements
- Be main contact for the local competent authority. Act as a local regulatory responsible person
- Provide regulatory support to commercial and in\-country local commercial teams
- Manage and maintain regulatory documentation, ensuring it complies with applicable regulatory standards and guidelines
- Assist with effective, consistent, and reliable Product Surveillance
- Be responsible for complaint handling (submission, coordination of product return, follow\-up investigation)
- Liaise with FSCA team and regional stakeholders to initiate recalls
- Handling the Field Safety Notices to the affected customers, reports the reconciliation of products and customers acknowledgment to the PMS team or FSCA Team
- Be responsible for the handling of instructed actions like Field Notices (FN), Product Holds
- Plan, support and join the internal and external audits
- Ensure the Audit preparation activities and support for auditees. Ensure follow\-up on Audits (Internal/EMEA/External) as appropriate and required by the internal procedures
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- Ability to handle high volume of correspondence and prioritize work accordingly
- Ability to work independently and collaboratively in a team\-oriented environment.
- Ability to prepare high quality, clear communication materials to the appropriate audience
- Excellent communication and interpersonal skills.
- Ability to work with accuracy and precision.
- Diplomacy and tenacity.
- Discretion and confidentiality
- Ability to work in a multinational team.
- Ability to adapt to changing environment.
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You hold a B.S. or M.S. degree in biomedical/clinical engineering, pharma, biological or medical science (or equivalent experience) alongside with 5\+ years’ experience in registration/notification activities and/or quality assurance in medical devices area.
You have a comprehensive knowledge of regulatory requirements and legislation in Portugal.
In addition you are fluent in Portuguese, Spanish and English.
Travel Expectations
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Up to 5%.
The role is ideally based in Barcelona, Spain. Other locations in Spain or in Portugal could be considered.
EOE/M/F/Vet/Disability
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