Regulatory Affairs Associate Specialist

2 weeks ago

dubai, United Arab Emirates Edwards Lifesciences Gruppe Full time
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Regulatory Affairs Associate Specialist Apply locations United Arab Emirates-Dubai time type Full time posted on Posted 2 Days Ago job requisition id Req-32380

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.

This is a regulatory affairs role within Middle East and Africa region for a 1 year contract.

How you will make an impact:

  • Lead the collaborative creation with stakeholders (e.g., COE) on regulatory submissions/playbook, exercising judgment to protect proprietary information) for finalization and submission; manage timelines and document milestone achievements, participate in developing regulatory strategy, prioritize regulatory activities with operating plans as well as ensuring alignment in assigned countries/area of work (e.g., country clusters, COE, MEA)

  • Identify trends, assess impact, analyze alternatives and recommend action plans

  • Participate in targeted engagements to strengthen regulatory relationships, expand networks of influence and support initiatives (e.g., strategic company interests, regulatory intelligence)

  • Participate in representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, and resolving conflicts between those requirements and development issues, and/or reporting to management.

  • Prepare documents for submissions, including assuring the appropriate forms for all appropriate regulatory bodies

  • Participate in providing guidance and feedback to stakeholders on regulatory activities (e.g., strategies, contingency plans, registration requirement) including assessing impact to appropriate regulations

  • Review and approve materials (e.g., collateral) from cross-functional teams

What you’ll need (Required):

  • Bachelor's Degree in Biology, Microbiology, Chemistry, Biomedical Engineering and/or business

  • 3 Years of experience in regulatory frameworks in the North African Region - Mainly Egypt, Algeria, Morocco and Tunisia with possibility of geographical expansion to other MEA territories

  • Experience within Ministry of Health (preferred)

  • Experience in preparing domestic and international product submissions

  • Involvement in Ministry of Health meetings and trade association discussions

  • Ability to read, write and speak English required; Fluency in other language (e.g., Arabic, French) is preferred

What else we look for (Preferred):

  • Good medical writing skills

  • Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel

  • Good problem-solving, decision-making, organizational, analytical and critical thinking skills

  • Good written and verbal communication skills and interpersonal relationship skills

  • Solid knowledge and understanding of global regulations relevant to medical devices (e.g., Class I, Class II and/or Class III devices)

  • Solid knowledge and understanding of global regulatory requirements for new products or product changes.

  • Solid knowledge of new product development systems

  • Strict attention to detail

  • Ability to interact professionally with all organizational levels

  • Ability to manage competing priorities in a fast paced environment

  • Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects

  • Ability to build productive internal/external working relationships

  • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

About Us

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide. 

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

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