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PR/086904 | Regulatory Affairs and QA Supervisor (Onsite in San Diego, CA)
| 勤務地 | アメリカ合衆国, Vista |
| 雇用形態 | 正社員 |
| 給与 | 経験考慮の上、応相談 |
募集要項
Regulatory Affairs and QA Supervisor (Onsite in San Diego, CA)
RESPONSIBILITIES
- Facilitates audits by interacting with FDA, ISO, and international regulatory bodies.
- Manages the 510k regulatory submission process by compiling and submitting the necessary reports and documentation to internal and external submission partners.
- Works closely with Quality and the Risk Management team to identify and mitigate risk/issues.
- Files Vigilance Reports or MDR (Medical Device Report) to Competent Authority or FDA.
- Interacts between departments to coordinate and facilitate submissions.
- Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met.
- Works to minimize regulatory issues and helps prevent unnecessary regulatory delays.
- Evaluates changes to regulatory documents and formulates a strategy to ensure proper filing categories.
- Plan and implementation and maintenance of the QMS.
- Conduct internal audits to ensure compliance.
- Manage quality control over the entire submission lifecycle, including all component tracking, workflow execution and issue resolution.
- Evaluate changes and signs-off on change control documents, ensuring the correct filing category.
- Represent Quality Assurance on project teams interdepartmentally.
- Performs other duties, as assigned, or as business needs require.
REQUIREMENTS
- Minimum 3 years of QA/RA experience required
Bachelor's degree from four-year college or university; or 3+ years related experience and/or training
- Japanese language skills (Preferred)
- Excellent understanding of Food and Drug Administration (FDA) and international organization for standardization (ISO) regulations
To perform this job successfully, an individual should have knowledge of: Database Software (EPDM); Spreadsheet Software (Excel); Project Management Software; Word Processing Software (Word); Electronic Mail Software (Outlook); Presentation software (PowerPoint).
Regulatory Affairs Certification Program (Preferred)
USD 90,000 - 110,000 DOE
Comprehensive health benefits, 401k, PTO
- Onsite in San Diego, CA
- This role is NOT visa sponsored
#LI-JACUS #LI-US #countryUS
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応募必要条件
| 職務経験 | 3年以上 |
| キャリアレベル | 中途経験者レベル |
| 英語レベル | ビジネス会話レベル |
| 日本語レベル | ビジネス会話レベル |
| 最終学歴 | 短大卒： 準学士号 |
| 現在のビザ | 日本での就労許可は必要ありません |
勤務地
- アメリカ合衆国, Vista
労働条件
| 雇用形態 | 正社員 |
| 給与 | 経験考慮の上、応相談 |
| 業種 | 医療機器 |
職種
- その他 > その他
