Clinical Specialist

Kiwa is a world top 20 leader in Testing, Inspection and Certification (TIC). With our certification, inspection, testing, training and consultancy services, we create trust in our customers' products, services, processes, (management) systems and employees. We do so in a wide variety of markets segments, ranging from construction and energy supply to drinking water, healthcare, food, feed & farming. Kiwa employs over 10,000 people in over 40 countries, in Europe, Asia, the Americas and Oceania. Since 2021 we are a member of SHV Family of Companies. We are looking for a ‘Clinical Specialist’ to join our company for our Medical Division, located in Tuzla, İstanbul.

‘Clinical Specialist’ plays a crucial role in ensuring that medical devices meet the required safety and performance standards as per Medical Device Regulation (MDR). Their responsibilities include:

• Assessing Clinical Data: Evaluating clinical data provided by manufacturers to determine whether it supports the safety and performance claims of the medical device. This involves assessing clinical reports, trials, and other relevant data.
• Evaluating Post-Market Data: Analyzing post-market clinical data, including adverse event reports and real-world performance data, to ensure ongoing compliance with MDR requirements and addressing any issues that arise.
• Assessing Risk Management: Reviewing the risk management processes related to the clinical aspects of the device, including assessing the risk-benefit ratio and ensuring that appropriate risk mitigation strategies are in place.
• Supporting Technical Documentation: Evaluating the technical documentation provided by manufacturers to ensure that it includes comprehensive clinical evidence and meets the regulatory standards set out in the MDR.
• Ensuring Compliance with Regulations: Supporting the Notified Body in making informed decisions about device approvals or certifications by ensuring that clinical aspects of the device are thoroughly assessed and comply with the MDR.
• Maintaining their qualification: Providing an annual performance status update of their assigned role to maintain regulatory requirements by attending scheduled periodic training and other on-the-job activities.

• Degree in medicine and a specialization in a clinical area (medical specialist must have completed their residency)
• Currently employed and actively practicing medicine in the relevant field within a healthcare setting
• Fluent in English
• At least 4 years of clinical practice, related to the use of medical devices, the pathology of the condition to be treated and the relevant consolidated and alternative treatments in relation to the devices and other products
• Basic knowledge of current EU legislation regulating medical devices (EU Regulation 2017/745, supervisory requirements, etc.) and harmonized standards (e.g., ISO 14155, ISO 14971)
• Ability to draw up records and reports that demonstrate the correct performance of the relevant clinical data evaluation activities
• Good command of MS Office programs
• Attentive to details, high comprehension skills, proactive approach, risk oriented planning.

Professional Development:

• Training and Education: Opportunities for ongoing education and training in the latest regulatory updates, clinical evaluation techniques, and advancements in medical technology
• Conferences and Workshops: Access to industry conferences, seminars, and workshops that enhance knowledge and networking opportunities.

Career Growth:

• Career Advancement: Clear pathways for career progression within the Notified Body, including roles with increased responsibility or specialization, and developing a profession recognized throughout the entire European Union
• Skill Enhancement: Development of specialized skills in regulatory affairs, clinical evaluation, and risk management

Diverse Experience:

• Varied Exposure: Experience working with a wide range of medical devices and technologies, from innovative startups to established products.
• Cross-functional Collaboration: Opportunities to collaborate with professionals across various disciplines, including regulatory experts, auditors, and engineers

Competitive Compensation:

• Salary and Benefits: Competitive salary packages and benefits, which may include health insurance, retirement plans, and other perks.
• Performance Bonuses: Potential for performance-based bonuses or incentives based on individual and organizational achievements.

Professional Recognition:

• Industry Credibility: Recognition as an expert in clinical evaluation and medical device regulation, enhancing your professional reputation
• Networking Opportunities: Opportunities to connect with key stakeholders in the medical device industry, including manufacturers, regulators, and healthcare professionals

Impactful Work:

• Contribution to Safety: A direct role in ensuring that medical devices meet high safety and efficacy standards, impacting patient safety and public health
• Influence on Standards: The ability to influence industry standards and practices through rigorous evaluation and assessment

Work Environment:

• Dynamic Challenges: A stimulating work environment with varied responsibilities, keeping the role engaging and challenging
• Supportive Culture: A collaborative and supportive work culture focused on professional excellence and continuous improvement

Global Perspective:

• International Exposure: Experience with international regulatory requirements and practices, which can be valuable for a global perspective on medical device regulation

Innovation and Learning:

• Exposure to Cutting-edge Technologies: Interaction with the latest advancements in medical technology and innovations
• Problem-Solving: Opportunities to tackle complex regulatory and clinical challenges, enhancing problem-solving skills

Overall, a role as a Clinical Specialist in a Notified Body offers a dynamic and impactful career path, with opportunities for professional development and significant contributions to medical device regulation and public health.