Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

Tailor your resume to this Manager, Orthopaedics, Regulatory Affairs role.

Rezi rewrites your resume against Stryker's job description. Free.

Resume score gauge reading 58 out of 100

Don't guess if your resume is good enough.

See how it scores against the Manager, Orthopaedics, Regulatory Affairs posting at Stryker — free, in seconds.

About the Role

Under minimum supervision, this role involves understanding relevant laws and regulations to efficiently conduct duties such as approval applications, notifications, and other related tasks for medical devices manufactured and distributed by Stryker Japan K.K.

Responsibilities

Manufacturing and distribution/certification approval, notifications (including planning, collecting data, and PMDA/NB query correspondence)
Maintenance of approvals and certifications (Change control and periodical renewal)
QMS compliance inspection applications
Insurance listing applications (Creation of insurance listing application forms)

Requirements

Ability to write business documents
Good communication skills and project management skills
Please describe in detail the history of approval / certification application and the role you played in your resume.

Skills

English (reading and writing)
Business document writing
Communication skills
Project management skills

Location

Onsite
Hybrid

Work Type

Hybrid
Onsite

Experience Level

6+ years of experience of medical device (Class I to IV) application approvals
Experience of PMDA consultation, and application approvals of improved device (preferably Class IV)

Education Level

English (reading and writing)
Ability to write business documents