Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world. 

Job's Mission

• A Manager the in the group shall work closely with the Head in the group to ensure that all safety vigilance operation for Santen Medical devices is appropriate in terms of structure and performance, to comply with global standards, policies and procedures related to Safety vigilance.
• Improvements and harmonization of medical device QMS related to safety at EMEA and globally between regional/legal manufacture sites
• Further development/Improvement of medical device procedures and management at EMEA and global sites

KEY ACTIVITIES & ACCOUNTABILITIES

As a manager of person in charge of Safety Vigilance System, the position holder has the following primary responsibilities for Medical device:

• SOPs: Creation, review, maintenance, and update of uniform global safety Standard Operating Procedures
• Trainings: Conduct the safety vigilance on-boarding and/or continuous training to Santen employees and PV personnel
• Prepare/Maintain a medical device vigilance agreement in collaboration with Quality Assurance
• Lead EU local medical device projects/work streams and task forces
• Provides opinion to the overall processes, policies and procedures of global safety vigilance.

• Bachelor’s Degree in a life science. Preferred: Physician, Pharmacist.
• At least 3 years in medical device of safety vigilance
• Excellent knowledge of medical device regulations relating to safety vigilance especially MDR
• Excellent verbal and written communication skills
• Demonstrate working knowledge of MS Office application
• Ability to interact effectively in a multifunctional and multicultural team setting.

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer.  We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.