1 Regulatory specialist Job in Mettawa, IL
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intellectt is Hiring a Regulatory specialist Near Mettawa, IL
Role : Regulatory Specialist II
Location : Lake Forest, Illinois - 60045
Duration : 12 Months on W2
RESPONSIBILITIES :
- Responsible for technical writing of files in accordance with In Vitro Diagnostic medicaldevice Regulation (IVDR).
- Provides regulatory support for diagnostic product development and commercialdiagnostic products.
- Develops regulatory strategies for products in development and for modified products achieve clearance / approval in the EU and internationally.
- Provides regulatory support to regional regulatory teams to assist with submissions,license renewals, and license amendments.
- Researches and communicates scientific and regulatory information in order to writesubmission documents.
- Compiles and publishes all material required for submissions, license renewals, andannual registrations.
- Maintains approvals / licenses / authorizations for existing marketing authorizations.
- Assesses product, manufacturing, and labeling changes for regulatory reporting impactand compliance to regulations.
- Develops internal procedures and tools.
- Conducts informational or training sessions for stakeholders.
- Organizes and maintains hard copy and electronic department files.
- Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
- Responsible for exhibiting professional behavior with both internal / external businessassociates that reflects positively on the company and is consistent with the company'
s policies and practices.
BASIC QUALIFICATIONS EDUCATION
- Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience
- 4 years' experience in Regulatory Affairs role
- Strong knowledge of IVDR and EU regulatory requirements is required.
PREFERRED QUALIFICATIONS :
- 1 years' experience in an IVD or medical device manufacturing environment. COMPETENCIES
- Good knowledge of EU and international regulations
- Demonstrated written and verbal communication skills.
- Strong time management skills, with the ability to work on multiple projects simultaneously.
- Ability to work independently as well as within a team.
Last updated : 2024-04-28
Job Summary
Full Time
Business Services
$66k-85k (estimate)
04/29/2024
05/08/2024
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, ISO, Product Development, Chemistry, Verbal Communication, Time Management, 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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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.
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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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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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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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