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Regulatory Specialist II

3 months ago

Scarborough, Maine, United States Collabera Full time
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Regulatory Specialist II

Contract: Scarborough, Maine, US

Salary: $50.00 Per Hour

Job Code:

End Date:
Days Left: 28 days, 3 hours left

Apply

To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - ), email your updated resume at Email - or give me a call at Thank you

Job Description:
Job Roles & Responsibilities:
  • 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 our 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 MS Office, including Word, Excel, PowerPoint and Visio
Job Requirement
  • Regulatory Specialist
  • technical writing
  • In Vitro Diagnostic
  • IVD
  • IVDR
  • Medical Device Regulation
  • diagnostic
  • product development
  • EU
  • EU MDR
  • compliance
  • Medical Device
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  • Chitrank Rastogi
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