regulatory affairs manager - advanced surgical.

社名
社名非公開

職種
薬事、メディカルライティング

業務内容
Have a direct impact on improving patient health.
Inclusive and collaborative work environment.
Opportunities for professional and personal growth.

求められる経験
Qualifications:
● Sound basis of Regulatory knowledge in general
● Experience in creating and managing Class IV device submissions
● Sound basis of Regulatory knowledge in country of interest
● Scientific Knowledge – ability to understand Advanced Surgery products and uses
● Ability to manage complex projects and timelines in a matrix team environment
● Strong oral and written communication and presentation skills – ability to work closely and effectively with the Global RA and project teams.
● Demonstrated interpersonal skills including strong negotiation skills
● Ability to independently identify compliance risks and escalate when necessary
● Ability to lead and coach others – internal and external partners

Education & Experience:
● Bachelor’s degree or country equivalent in related scientific discipline with a minimum of 10 years regulatory experience in RA or related field, including managing people or projects. ...