Quality & Regulatory Affairs Specialist I

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

As a QARA Specialist you will be responsible for supporting the Quality Assurance & Regulatory Affairs function within Zimmer Biomet’s Sales and Distribution organization within your assigned region - Saudi Arabia. You will also ensure compliance with the requirements of ISO 13485 Quality Management System.

If this sounds interesting look no further, apply now!

How You'll Create Impact

• Support implementation, development, maintenance and control of a quality management system according to international standards and corporate guidelines/policies/procedures in assigned countries with QMS
• Assure an effective, consistent and reliable forward of information in terms of product surveillance on assigned region and local market following legal requirements and Zimmer Biomet procedures
• Ensure surveillance and forward of information concerning changes and/or new upcoming local legal requirements to assure the continuity of Zimmer Biomet’s business in assigned region
• Ensure awareness about QMS across the market and country with QMS (if applicable)
• Drive CAPAs and SCARs as per the internal procedures
• Participate, provide support and manage the Management Reviews, Risk Management Reviews, Supplier Review Boards, Distributor Review Board, CAPA Review Board meetings
• Be responsible for product registration and/or regulatory clearance in assigned market and all its countries in accordance with local in-country legal requirements, main contact for the local competent authority, where applicable, and responsibility for the maintenance of the business in the local market and distributors markets in assigned region
• Provide regulatory support to commercial and in-country local commercial teams, including support for tenders or delivery of regulatory documents for reimbursement or other commercial activities
• Act as a local regulatory responsible person, if required by local in-country law
• Support the team and QA/RA EMEA with QA/RA standardization of processes
• Work on continuous improvement of our processes
• Where applicable, plan, support and join the internal and external audits in assigned region as appropriate
• Ensure continuous communication, reporting and escalations to the QA/RA manager/supervisor
• Support other Zimmer distribution organizations with regard to QA/RA requirements (e.g. product registrations, notifications or renewals)
• Get involved in special projects and special duties on the country or EMEA level, like (re-) validation of technical systems and procedures, implementation of new tools etc. as per the assignment of the direct manager
  
  

What Makes You Stand Out

• Ability to handle high volume of correspondence and prioritize work accordingly
• Work both independently as well as collaborate with stakeholders across all organization
• Ability to prepare high quality, clear communication materials to the appropriate audience
• Discretion and confidentiality
• Education necessary to act as a local regulatory responsible person
  
  

Your Background

• B.S. or M.S. degree in biomedical/clinical engineering, pharma, biological or medical science or equivalent experience required
• 3 to 5 years’ experience in registration/notification activities and/or quality assurance in medical devices, pharma or veterinary area
• Knowledge of ISO 9001, ISO 13485
• Knowledge of national medical device regulations, knowledge of MDD/MDR
• Experience with Windows Office Software, especially Excel and Power Point, and SAP
• High standard of English / writing skills
  
  

Travel Expectations

5%

EOE/M/F/Vet/Disability

5062