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Senior Regulatory Affairs Specialist - Tokyo, 日本 - Fortive
説明
Position Summary
The Senior Regulatory Affairs Specialist (Sr, RA Specialist) is responsible for developing regulatory strategies, preparing Local submissions and supporting international submissions to obtain and maintain approval/certification for drug/device products and therapies to markets globally. Additionally, the Sr, RA Specialist is responsible for product life cycle management through assessment of drug/device changes for regulatory implications and for performing regulatory activities in support of implementing these drug/device changes. The Sr RA Specialist supports cross-functional teams by advising teams on applicable global regulatory requirements, standards and requirements to ensure regulatory compliance. The Sr. RA Specialist is responsible for practical control of drug/device advertising and promotional requirements.
Duties and Responsibilities
Under general supervision. and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:
· Evaluates the regulatory environment and contributes to providing internal assessment throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
· Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and solves minimally to moderately complex problems using existing solutions
· Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
· Evaluates proposed products for regulatory classification and jurisdiction
· Works with global regulatory team to determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
· Provides regulatory input and technical guidance on global regulatory requirements to product development teams
· Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
· May facilitate projects with manageable risks and resource requirements
· Evaluates proposed manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
· Supervise regulatory notices, guidance, and review for proposed product claims/labeling. Assess the technical information, clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.
· Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines and monitors the progress of the regulatory authority review process through appropriate communications with the agency.
· Communicates and interacts with local regulatory authorities before and during the development, review of a regulatory submission and maintenance of approval/certification through appropriate communication tools.
· Communicates and interact with local regulatory authorities to establish and maintain business related licenses and foreign manufacturer registration
· Works with cross-functional teams for interactions with regulatory authorities.
· Responsible for communicating business related issues or opportunities to next management level.
· Plan internal/external audit and support the readiness.
· Performs other duties assigned as needed.
Education:
Bachelor's Degree
Years of Related Experience:
§ Minimum of 4 years related work experience
§ Minimum of 2 years of experience with MS, or equivalent knowledge and skills, necessary to satisfactorily perform the position's responsibilities.
§ Related Regulatory and/or Quality Assurance experience.
Nice to Have:
5+ years medical device industry experience.
Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
New product development experience.
Application for approval (certification) or authorization experience.
Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:
(Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)
· Proper application of Japan Pharmaceutical Affairs Law, QMS ordinances, and various other regulations.
· Proper application of Quality Management System Standard ISO 13485.
· Proper application of Risk Management Standard ISO 14971.
· Understanding of US and EU pharmaceutical regulations.
· Excellent written and oral communication skills.
· Good and analytical thinking, problem solving and investigative skills.
· Proficiency in Microsoft Office and all related applications.
Fortive Corporation Overview
Fortive's essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.
We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We're a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.
We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.
At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference.
At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.
At Fortive, we believe in growth. We're honest about what's working and what isn't, and we never stop improving and innovating.
Fortive: For you, for us, for growth.
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