Ra Specialist / Risk Management & Pms

Occlutech Tıbbi Ürünler San. Ve Tic. Ltd. Şti.

About Occlutech

Occlutech is a leading specialist provider of minimally invasive cardiac devices, with a mission to improve the quality of life for people with heart conditions. The vision is to become a global leading specialist provider in cardiac devices, addressing congenital heart defects, stroke prevention, and heart failure.

Occlutech has a broad and proven portfolio, based on proprietary technology, and over 200 patents with more than 139,000 products sold. The company markets and sells its products in circa 85 countries and has around 320 employees.

Location: Istanbul, Turkey

Position: Regulatory Affairs Specialist/Risk Management and Post Market Surveillance(m/f/d)

The Regulatory Affairs Specialist/Risk Management and Post Market Surveillance ensures the compliance of the risk management and post market surveillance process according to the regulations and our quality management system and interacts with the international risk and post market team. The Regulatory Affairs Specialist maintains, reviews, and approves risk management and post market surveillance documentation and coordinates technical experts, deploying best practice in risk management and post market surveillance, standard operating procedures and general guidance. In this role, you will disseminate knowledge and awareness of risk management and post market surveillance within the Occlutech organization, support, among others, customer complaints, CAPA.

Your work will focus on:

• Collecting, trending and escalating data related to Post Market Surveillance
• Management of product risk documents during the entire product life cycle
• Plan and perform risk management activities with the Occlutech organization
• Generating, maintaining and completing the Post Market documentation (Periodic safety update report, PMS report & Plan) subject to review by regulatory agencies
• Preparing and presenting Post Market Surveillance Reports to the Management
• Supporting life cycle management esp. during post-market life cycle phase in collaboration with complaints department and medical device safety officer
• Support management of process for risk assessment
• Collaboration with all departments involved in risk management activities
• Support implementation of risk management best practice, standard operating procedures and general guidance for the application of risk management in device development and post market phase
• Support dissemination of knowledge and awareness of risk management within Occlutech
• Support identifying opportunities for improvement in risk management
• Provide risk assessment/review into various processes (e.g CAPA, changes, complaints)

We are looking for a candidate, who

• Has a Bachelor’s or Master’s degree in life science or engineering (or related field)
• Has a university degree (min. Bachelor) preferably Master’s degree in life science or engineering or related field
• Has at least 2 years of professional experience in post-market surveillance and/or risk management in the medical device industry
• Has knowledge of and practical experience QMS (ISO13485:2016/MDSAP/U.S. FDA QSR) and MDD / EU-MDR
• Has excellent written and verbal communication skills in English
• Is able to work independently, adapt to changing tasks in a fast and dynamic work environment and manage multiple tasks
• Has good organizational, interpersonal and problem-solving skills and is able to collaborate with cross-functional teams
• Is proficient in Microsoft Office applications