1 Regulatory Specialist Job in Des Plaines, IL
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Advanced Clinical is Hiring a Regulatory Specialist Near Des Plaines, IL
We are currently searching for a skilled professional to join a well-known client's team as a Regulatory Specialist in Des Plaines, IL. The Regulatory Specialist role will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
* 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.
EXPERIENCE
Must have 1-2 years of experiences in Medical Device Reg Affairs
EDUCATION
BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.
To be a best-fit your strengths must include:
* Knowledge of regulations and standards affecting IVDs and/or biologics
* Have working knowledge in EU MDR
* Have working knowledge in Regulatory Change Assessments
* Have working knowledge in US and EU medical device submissions
* Work cross-functionally and in a matrixed environment
* Have experience with continuous improvement activities
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About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
Job Summary
Full Time
Scientific Services
$67k-87k (estimate)
04/12/2024
05/22/2024
advancedclinical.com
SOUTH MIAMI HEIGHTS, FL
1,000 - 3,000
2018
ABEL PEREZ
<$5M
Scientific Services
Related Companies
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.
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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.
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works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products.
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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.
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Successful regulatory specialists are excellent writers, as they must write details and accurate reports for the evaluations they perform.
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Earn Regulatory Affairs Professionals Society certifications.
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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.
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Step 3: View the best colleges and universities for Regulatory Specialist.
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