Regulatory Affairs and QA Supervisor (Onsite in San Diego, CA)
Top Benefits
About the role
A Medical device manufacturing company is looking for a Regulatory Affairs and QA Supervisor (or Specialist). This position is primarily responsible for overseeing all Regulatory and QA functions for the company by the following duties. Reporting to the CEO.
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)
SALARY & BENEFIT
- USD 90,000 - 110,000 DOE
- Comprehensive health benefits, 401k, PTO
- Onsite in San Diego, CA
- This role is NOT visa sponsored
#countryUS
About JAC Recruitment
JAC Recruitment, listed on the first section of the Tokyo Stock Exchange, is one of the very few recruitment consultancies providing specialised services for medium-to-high-income job positions such as specialists, middle management positions and executives.
The Group has over 45 years of history since its foundation in 1975 in the United Kingdom. Its Japanese subsidiary was opened in 1988 and has been driving the recruitment industry in Japan for over 30 years. We are now operating across 34 offices in 11 countries. have a presence in the U.S., the United Kingdom, Germany and 7 Asian countries (Singapore, Malaysia, Indonesia, Thailand, South Korea, Vietnam, India).
With our global network operating across 11 countries, we are contributing to the growth of our client companies’ global business expansions by providing services for Japanese, foreign capitalized and local company clients. To satisfy the recent increasing demand of talent in the latest technology areas such as DX, IoT, AI and robots, we are strengthening digital-related recruitment services through our brand “JAC Digital” as a company-wide project.
From the end of 2020, we have started to provide two additional recruitment-related services: “Interim Management Solutions (IMS)" specializing in solving management issues with the aim of responding to the diverse work style needs of high-skilled personnel, and “Recruitment Process Optimisation (RPO)" to solve corporate recruitment issues.
All of our 1,830 staff around the world continue aiming to gain trust and support by our customers by improving our service quality.
Regulatory Affairs and QA Supervisor (Onsite in San Diego, CA)
Top Benefits
About the role
A Medical device manufacturing company is looking for a Regulatory Affairs and QA Supervisor (or Specialist). This position is primarily responsible for overseeing all Regulatory and QA functions for the company by the following duties. Reporting to the CEO.
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)
SALARY & BENEFIT
- USD 90,000 - 110,000 DOE
- Comprehensive health benefits, 401k, PTO
- Onsite in San Diego, CA
- This role is NOT visa sponsored
#countryUS
About JAC Recruitment
JAC Recruitment, listed on the first section of the Tokyo Stock Exchange, is one of the very few recruitment consultancies providing specialised services for medium-to-high-income job positions such as specialists, middle management positions and executives.
The Group has over 45 years of history since its foundation in 1975 in the United Kingdom. Its Japanese subsidiary was opened in 1988 and has been driving the recruitment industry in Japan for over 30 years. We are now operating across 34 offices in 11 countries. have a presence in the U.S., the United Kingdom, Germany and 7 Asian countries (Singapore, Malaysia, Indonesia, Thailand, South Korea, Vietnam, India).
With our global network operating across 11 countries, we are contributing to the growth of our client companies’ global business expansions by providing services for Japanese, foreign capitalized and local company clients. To satisfy the recent increasing demand of talent in the latest technology areas such as DX, IoT, AI and robots, we are strengthening digital-related recruitment services through our brand “JAC Digital” as a company-wide project.
From the end of 2020, we have started to provide two additional recruitment-related services: “Interim Management Solutions (IMS)" specializing in solving management issues with the aim of responding to the diverse work style needs of high-skilled personnel, and “Recruitment Process Optimisation (RPO)" to solve corporate recruitment issues.
All of our 1,830 staff around the world continue aiming to gain trust and support by our customers by improving our service quality.