Regulatory Affairs Specialist in Alameda, CA

  • Title: Regulatory Affairs Specialist
  • Code: RCI-35139
  • RequirementID: 117338
  • Location: Alameda, CA 94502
  • Posted Date: 04/23/2024
  • Duration: 12 Months
  • Salary ($): 51.97 - 54.64 per Hourly
  • Apply Create Job Alert
Talk to our Recruiter

  Job Description

POSITION IS 1 YEAR FROM START DATE WITH POSSIBLE EXTENSIONS.

On-Site 

Top experience manager is looking for:
  • Risk management,
  • Product management,
  • Product registrations,
  • Impact assessment knowledge
Chinese or Japanese bilingual- optional.

Occasional Night call- 4-5 PM, 5-6 PM or 6-7 PM

Team environment- 5 people currently. Very open and collaborative team.

 

Experience Background :

  • Medical Device, Pharmaceutical, Regulatory Affairs, Quality Assurance, SW Engineering, APAC regulatory submission, or APAC-related work under Quality Assurance/Engineering.

Job Description

  • Keep the training records up to date to do the tasks.
  • Report the status to a manager weekly.
  • Plan and execute the given tasks proactively in a timely manner.
  • Communicate weekly with affiliate RAs in different time zones to catch up on ongoing projects and discuss the issues to solve.
  • Understand country-specific requirements and deliver those to internal stakeholders, including product management, engineering, labeling, etc., for product registration and change planning.
  • Responsible for regulatory activities, including product registrations, impact assessment, etc.
List any preferred requirements that would stand out on a resume:
  • Years of experience required: 5+ Required
  • Understand technical sections (risk management, product change control, biological evaluation)
  • Education level/certifications: BS, MS
Daily tasks/duties and department interactions:
  • prep submissions, regulatory strategy, review change control, other assigned tasks.
  • Interacting with QA, Labeling, Engineer, PMO. Etc.
Description of work environment/department:
  • Assigned Desk, quiet area but dynamic work
  • Occasional night calls (after 5PM) with Affiliates.
Preferred interview method (one step or two step/phone or video conference): video interviews- two step interviews

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.

 



About Rangam:

Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. Specialized in attracting and retaining talents globally for a rewarding career in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, be it jobs in USA, UK, India, or Ireland. Also remote jobs, work-from-home jobs, or contract jobs in different verticals and industries.
Rangam strives to put job seekers first, giving them free access to search for jobs, post resumes, and research companies.Every day, we connect millions of people to new opportunities.

Apply Create Job Alert