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Regulatory Affairs Specialist II
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Collabera Scarborough, United StatesJob Description · Job Description · The position of · Regulatory Affairs Specialist II · is within our Infectious Disease business unit. · In this role you will prepare documentation for EU Technical Files and international product registrations. · This job description will b ...
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Regulatory Affairs Specialist II
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Collabera Scarborough, United StatesJob Description · Job Description · The position of Regulatory Affairs Specialist II is within our Infectious Disease business unit. In this role you will prepare documentation for EU Technical Files and international product registrations. · This job description will be review ...
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Regulatory Specialist II
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The Fountain Group Scarborough, United StatesHello,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-$56Experience:2-5 years regulatory experience and/or 2 ...
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Regulatory Specialist II
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Collabera Scarborough, United StatesHome · Search Jobs · Job Description · Regulatory Specialist II · Contract: Scarborough, Maine, US · Salary: $50.00 Per Hour · Job Code: · End Date: · Days Left: 9 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitrank Rasto ...
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Regulatory Specialist II
5 days ago
Collabera Scarborough, United StatesHome · Search Jobs · Job Description · Regulatory Specialist II · Contract: Scarborough, Maine, US · Salary: $50.00 Per Hour · Job Code: · End Date: · Days Left: 12 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitrank Rast ...
Regulatory Affairs Specialist - Scarborough, United States - TalentBurst
Description
Title:
Regulatory Affairs Specialist II
Location Scarborough Maine
Duration 6 months
The position of Regulatory Affairs Specialist II is within our Infectious Disease business
unit. In this role you will prepare documentation for EU Technical Files and international
product registrations.
This job description will be reviewed periodically and is subject to change by management.
RESPONSIBILITIES:
Responsible for technical writing of files in accordance with In Vitro Diagnostic medical
device Regulation (IVDR).
Provides regulatory support for diagnostic product development and commercial
diagnostic products.
Develops 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 in order 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 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
Client Quality Management System per ISO, FDA, and other regulatory agencies.
Responsible for exhibiting professional behavior with both internal/external business
associates 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.
Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio
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