Senior Regulatory Affairs Specialist- Asia Pacific
Supports Regulatory Affairs activities for Arthrex, Inc.
Essential Duties and Responsibilities:
- Prepares, writes and submits regulatory filings
- Completes product registration activities
- Gathers information and data from other departments and external resources for regulatory submissions
- Reviews and approves advertising and promotional materials
- Develops regulatory strategy
- Performs technical and scientific regulatory activities
- Participates in regulatory or quality systems audits as required
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.
Education and Experience:
Bachelor's degree required.
7 years direct experience and training in regulatory affairs.
Strong interpersonal, oral and written communication skills required.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
- Interpersonal and communication skills
- Proficient in one other language preferred
- Proficient in Microsoft Office
- Ability to work in fast paced environment
- Strong written communication skills
- Ability to independently manage multiple projects over extended periods of time
- Internal and external communication and collaboration skills
- Subject Matter Expert for at least one region or product type
- Advanced understanding of regulatory framework and regulatory requirements for multiple regions
- Comprehensive understanding of orthopedic technical/ engineering/medical terminology preferred
- Knowledge of product lifecycle
- Knowledge of Asia regulatory affairs is preferred
Machine, Tools, and/or Equipment Skills:
PC, database, research tools, internet research tools.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Apply on company website