Quality Assurance & Regulatory Specialist
Roche
This job is no longer accepting applications
See open jobs at Roche.See open jobs similar to "Quality Assurance & Regulatory Specialist" Greatness.bio.Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
Who we are
Roche is ranked among the world's foremost corporations providing innovative healthcare
solutions, continuously investing in medical research and development.
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of
healthcare. Working together, we have become one of the world’s leading research-focused
healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.
The Opportunity
This is an excellent opportunity for an experienced professional to join Roche Diagnostics
Key Responsibilities
● Responsibility for the regulatory processes of the company's products in Israel, including
regulatory approval of new products, changes in registration and renewal of existing licenses
● Responsibility for the local modifications of relevant packaging materials.
● Serves as liaison with internal/external customers including interaction with the Ministry
of Health, Headquarters teams and international counterparts.
● Responsible for GSP compliance in accordance with Roche’s QMS.
● Training & Communication - oversees quality & related training, communication processes.
● Support for safety and quality notifications including recalls, regulatory reporting and the
collection of local customer and patients acknowledgements
● Quality audits management: Planning and execution of regular internal & external quality
audits
● Ensuring compliance with all Roche corporate business principles, Code of Conduct, policies and practices.
Qualifications
● Relevant Academic degree in life sciences (Masters degree – an advantage).
● Minimum 5 years of proven experience in a regulatory or safety role, preferably in amultinational company.
● Expertise in local registration guidelines.
● Experience as liaison with the Ministry of Health.
● Experience with ISO 9001 implementation.
● Experience in Quality Assurance - an advantage
● Attention to details and experience with global regulatory computerized interfaces - an asset
● Excellent written and oral communication skills in Hebrew and in English.
● Excellent interpersonal skills, able to work independently or as part of a team.
● Excellent learning capabilities, self-motivated, self-managed, ambitious, proactive behavior.
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.
This job is no longer accepting applications
See open jobs at Roche.See open jobs similar to "Quality Assurance & Regulatory Specialist" Greatness.bio.