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Regulatory Specialist
intellectt Alameda, CA
$80k-104k (estimate)
Contractor | Business Services 1 Month Ago
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intellectt is Hiring a Regulatory Specialist Near Alameda, CA

Hi, This is uday from Intellect Inc. One of our clients are looking for regulatory Specialist if you are interested send your updated resume to the mail uday@intellectt.com or you can give a direct call at 1 732-201-2258Role: Regulatory Specialist
Location: Alameda, CA | On-Site (5-days a week)
Duration: 12 Months | POSSIBLE EXTENSION
Shift Timings: 8 AM to 5 PM
Job Description
  • 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.
Experience And Knowledge Needed
  • 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.
  • Experience Background (Any): Medical Device, Pharmaceutical, Regulatory Affairs, Quality Assurance, SW Engineering, APAC regulatory submission, or APAC-related work under QualityAssurance/Engineering.
Preferred: Bilingual (Japanese or Chinese)

Job Summary

JOB TYPE

Contractor

INDUSTRY

Business Services

SALARY

$80k-104k (estimate)

POST DATE

04/29/2024

EXPIRATION DATE

10/20/2024

WEBSITE

intellectt.com

HEADQUARTERS

ISELIN, NJ

SIZE

200 - 500

FOUNDED

2018

CEO

KIRAN MADALA

REVENUE

$5M - $10M

INDUSTRY

Business Services

Related Companies
About intellectt

Intellectt Inc. was founded to set a new standard in Consulting and Staffing Industry. Our company is made up of dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. Intellectt Inc. and our affiliated brands provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and IT. We exist to become the finest and most esteemed staffing company across the USA and we look forward to putting our talents to use to push your organization forward.

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The job skills required for Regulatory Specialist include Product Registration, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Specialist. Select any job title you are interested in and start to search job requirements.

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The following is the career advancement route for Regulatory Specialist positions, which can be used as a reference in future career path planning. As a Regulatory Specialist, it can be promoted into senior positions as a Regulatory Affairs Specialist II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Specialist. You can explore the career advancement for a Regulatory Specialist below and select your interested title to get hiring information.

If you are interested in becoming a Regulatory Specialist, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Regulatory Specialist for your reference.

Step 1: Understand the job description and responsibilities of an Accountant.

Quotes from people on Regulatory Specialist job description and responsibilities

The regulatory specialist creates and maintains regulations for testing processes, the development phase, how production operates and the marketing and distribution for new products.

04/06/2022: Wilmington, NC

Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.

04/13/2022: San Antonio, TX

Certified regulatory affairs specialists typically collect and review marketing, legal, regulatory and licensing documentation, case files, studies, reports, etc.

02/13/2022: Manchester, NH

Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.

02/10/2022: Santa Fe, NM

works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products.

04/11/2022: Baton Rouge, LA

Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.

Career tips from people on Regulatory Specialist jobs

Entry-level regulatory affairs professionals must have a bachelor’s degree.

02/23/2022: Chico, CA

Successful regulatory specialists are excellent writers, as they must write details and accurate reports for the evaluations they perform.

02/24/2022: Newport News, VA

Earn Regulatory Affairs Professionals Society certifications.

03/14/2022: Saint Paul, MN

On successful completion of the program, graduates can take up roles such as regulatory affairs specialists.

03/19/2022: Ann Arbor, MI

At conferences and forums, specialists develop their existing knowledge and learn about emerging regulations, standards, and guidance documents.

04/28/2022: Lowell, MA

Step 3: View the best colleges and universities for Regulatory Specialist.

Butler University
Carroll College
Providence College
Rollins College
Taylor University
Amherst College