Regulatory Affairs Manager - Advanced Surgical

外資系企業上場企業大手企業英語力が必要土日祝休み

募集要項

募集背景: Overview:
Responsible for defining regulatory strategies and submissions in support of new and existing marketing authorizations for products for one or more countries. Typically, will supervise or mentor more junior employees.

仕事内容: Key Responsibilities:

● Develop and execute regulatory strategies/ plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations
● Lead the RA function on assigned cross-functional project teams
● Monitor applicable regulatory requirements; assure compliance with the company and external standards
● Establish appropriate communication within RA and other functions at the project level and to senior management
● Perform gap analysis and propose solutions
● Develop and document sound regulatory decisions and justifications
● Ensure project teams, business objectives and deliverables, and regulatory strategy are aligned
● May provide direct supervision of individuals
● May review promotional material or SOP’s for compliance with local and global regulations

応募資格

必須: 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.
● Higher degree/PhD will be an advantage. Ability to communicate effectively using Japanese and English.

事業内容・会社の特長: A global healthcare organization renowned for its commitment to advancing medical solutions and improving patient outcomes. With a rich history dating back several decades, this company operates on a global scale, offering a diverse portfolio of products and therapies across various healthcare domains.

Primarily focusing on lifesaving and sustaining solutions, this company specializes in developing and manufacturing a wide range of medical products. These include intravenous (IV) solutions, infusion systems, and other critical medical devices that play a vital role in patient care and treatment. The organization is dedicated to addressing the evolving needs of healthcare professionals and patients, with a focus on innovation and cutting-edge technology.

With a global presence, this medical company collaborates with healthcare providers, institutions, and professionals to deliver high-quality, reliable healthcare solutions. Its commitment to diversity, equity, and inclusion is evident in its workforce and corporate culture. The company values the diverse perspectives of its employees, fostering a collaborative and inclusive environment.