2 Jobs in Santa Clara, CA
intellectt is Hiring a Regulatory Specialist Near Santa Clara, CA
One of our medical clients is looking for the role Regulatory Specialist, if you are interested or your skills matches please share with me your updated resume tanmai@intellectt.com
Role: Regulatory Specialist Location: Santa Clara, CA Duration: 12 MonthsJob Description
- Support regulatory department for efficient and compliant processes.
- Execute tasks and collaborate across business functions and with suppliers.
- Assist in data collection for global product registrations.
- Prepare and submit registration documentation worldwide.
- Implement and maintain the effectiveness of the quality system.
- Support day-to-day manufacturing operations and change control.
- Provide regulatory advice for product development.
- Interpret and apply regulatory understanding to support products and teams.
- Prepare U.S. regulatory submissions and registration documents.
- Handle regulatory activities for documentation, labeling, and field support.
- Ensure compliance with quality systems and site/division-level policies.
- Education: BA Degree Required; Bachelor’s degree in Science, Math, Engineering, or Medical Fields preferred.
- Experience: 2-5 years in regulatory affairs, 2 years in relevant industrial roles, and 3-5 years in Medical Device Regulatory Affairs.
- Knowledge of IVDs and/or biologics regulations, EU MDR, regulatory change assessment, US and EU medical device submissions, cross-functional collaboration, and continuous improvement activities.
Job Summary
Full Time
Business Services
$84k-109k (estimate)
05/27/2024
07/07/2024
intellectt.com
ISELIN, NJ
200 - 500
2018
KIRAN MADALA
$5M - $10M
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.
The job skills required for Regulatory Specialist include Regulatory Affairs, 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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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.
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Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
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Certified regulatory affairs specialists typically collect and review marketing, legal, regulatory and licensing documentation, case files, studies, reports, etc.
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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
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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.
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At conferences and forums, specialists develop their existing knowledge and learn about emerging regulations, standards, and guidance documents.
04/28/2022: Lowell, MA
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