Regulatory Specialist II

3 weeks ago

Scarborough, United States Advanced Resources Remote Work Freelance Full time $60
Regulatory Specialist II6 Month Contract10 Southgate Road, Scarborough, Maine 04074$60 an hour 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 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 a 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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