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Regulatory specialist
Experis Forest, IL
$67k-88k (estimate)
Full Time | Business Services 2 Weeks Ago
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Experis is Hiring a Regulatory specialist Near Forest, IL

Experis IT ManpowerGroup has partnered with a leading Medical Device Co in the Lake Forest IL area for a Regulatory Specialist II role to assist their team. This is an Onsite role.

Industry : Medical Device Co

Title : Regulatory Specialist II

Location : ONSITE Lake Forest IL

Duration : 12 months

Shift : M-F 8 am - 5 pm

Pay : $41 per hour.

Job Description

  • This role will provide compliance support to the Regulatory Affairs organization by
  • Responsible for technical writing of files by In Vitro Diagnostic Medical

device Regulation (IVDR).

Provides regulatory support for diagnostic product development and commercial

diagnostic products.

Develop regulatory strategies for products in development and for modified products to

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 to write

submission documents.

Compiles and publishes all material required for submissions, license renewals, and

annual registrations.

  • Maintains approvals / licenses / authorizations for existing marketing authorizations.
  • Assesses product, manufacturing, and labeling changes for regulatory reporting impact

and compliance with regulations.

  • Develop 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

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
  • Last updated : 2024-05-14

Job Summary

JOB TYPE

Full Time

INDUSTRY

Business Services

SALARY

$67k-88k (estimate)

POST DATE

05/16/2024

EXPIRATION DATE

05/15/2024

WEBSITE

experis.us

HEADQUARTERS

CIUDAD DE MEXICO, CIUDAD DE MEXICO

SIZE

3,000 - 7,500

FOUNDED

2011

CEO

MONICA GRISELDA FLORES BARRAGAN

REVENUE

$10M - $50M

INDUSTRY

Business Services

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The job skills required for Regulatory specialist include Regulatory Affairs, Product Development, Chemistry, Technical Writing, 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.

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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.

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
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