Regulatory Affairs Specialist
Align Technology
- 서울시 강남구
- 정규직
- 풀타임
- Provides expertise to support business efforts locally based on RA requirements, and any other applicable worldwide regulatory requirement and business needs.
- Ensures product registrations are obtained and maintained as required.
- Functions as the RA voice of the country on applicable project teams. Where necessary, develop local documentation for product submissions based on specific country level regulatory requirements, to include the translation of applicable reports, labels, or other documents needed for submissions.
- Ensures that required Align, Suppliers and Distributors licenses/permits/certificates and KGMP certification needed to conduct business have been obtained and are maintained accordingly.
- Ensures continuous supply with internal & external regulatory compliance through on-time regulatory action such as product license variation, KGMP re-certification, MFDS re-evaluation and product license renewal.
- Review the GRP/GRIA on the new products and/or change plan for existing products, check Korea regulatory requirements, perform regulatory assessment, and provide the correct Korea regulatory requirements so that they can be reflected in the global plan.
- Review ad & promotional materials and provide a regulatory guidance according to global policy and local regulatory requirements as a regulatory reviewer.
- Assess and review PSAs, including locally occurring adverse event reports, and report in a timely in accordance with regulatory requirements.
- Knowledge of regulatory requirements for medical devices, including product registration and regulatory compliance practice from country scope.
- Experience in performing regulatory functions (e.g., writing submissions, reviewing documentation for regulatory compliance, interfacing with regulatory agencies, etc.) and medical device, KC, software-related regulatory requirements.
- Ability to work cross-functionally with multiple projects and communicating issues.
- Ability to execute project/program tasks with general supervision and little guidance.
- More than 5-8 years of experience in RA role at medical device company is required.
It is our policy to provide equal employment opportunity in all of our employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Align must be legally authorized to work in the country which they are applying for and verification of employment eligibility will be required as a condition of hire.#LI-AL1 / #LI-onsite