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Hello,
This is ShivaRaj from The Fountain Group, we are currently seeking a Regulatory Specialist II for a prominent client of ours.
This position is located in Scarborough, ME. Details for the position are as follows :
Pay : $47-$56
Experience :
2-5 years regulatory experience and / or 2 years relevant industrial experience typically with a quality, product-development / support, or scientific affairs function
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.
Duties :
Responsible for implementing and maintaining the effectiveness of the quality system.
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.
Last updated : 2024-05-21
Full Time
Business Services
$66k-86k (estimate)
05/23/2024
07/31/2024
thefountaingroup.com
TAMPA, FL
500 - 1,000
2001
HUNTER CONE
$10M - $50M
Business Services
The job skills required for Regulatory specialist include Chemistry, Change Control, 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.
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.
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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
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.