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Regulatory Specialist II

Alameda, CA 94502

Posted: 05/10/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 605804 Is job remote?: No Country: United States

Job Description


Duties:
  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Supports manufacturing/operations day to day activities for change control.
  • Provides consultation/advice to regulatory specialist for change control and product development.
  • Provides regulatory direction/interpretation on team activities.
  • Interprets and applies regulatory understanding to support of products and teams.
  • Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
  • Handles regulatory activities involved in documentation, labeling, field support.
  • Applies regulatory and technical knowledge to a wide variety of complex work assignments.
  • Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
  • Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.


Job Description (Expectation)

•    Responsible for regulatory activities, including product registrations, impact assessment, etc.
•    Understand country-specific requirements and deliver those to internal stakeholders, including product management, engineering, labeling, etc., for product registration and change planning.
•    Communicate weekly with affiliate RAs in different time zones to catch up on ongoing projects and discuss the issues to solve.
•    Plan and execute the given tasks proactively in a timely manner.
•    Report the status to a manager weekly.
•    Keep the training records up to date to do the tasks.

Other

•    Knowledge of International Standards, such as ISO13485, IEC60601.
•    Knowledge of APAC country regulations, such as TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, MOH, etc.
•    Knowledge of Agile, SharePoint, MS Office, and other software to increase work efficiency.
•    Ability to manage time and projects.
•    Strict to work 40hrs per week.

Skills:
  • Knowledge of regulations and standards affecting IVDs and/or biologics
  • Education: BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.





Pay Rate Range: $40-55/hr. Salary will be commensurate with experience

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Alameda, CA

Ready to kickstart your career in the vibrant and thriving area around Alameda, California? This picturesque region, nestled in the San Francisco Bay Area, offers an abundance of job opportunities with a backdrop of stunning views and a rich cultural scene. Discover the charm of Alameda with its historic landmarks like the USS Hornet Museum, unique cuisine at Alameda's vibrant restaurants, and diverse entertainment options at venues like the Alameda Theatre & Cineplex. With easy access to outdoor activities at Crown Memorial State Beach and the Alameda Marina, this area provides the perfect blend of work and play. Explore our job listings today and make your mark in this enchanting location!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.