Position Title: Regulatory Specialist
Work Location: South Portland, ME 04074
Assignment Duration: 12 Months
Work Arrangement: Onsite
 
Position Summary: Our organization's Rapid Diagnostics is part of our organization’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
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.
 
Key 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 organization 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.

 
Qualifications & Experience:

• 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.
• 1+ years’ experience in an IVD or medical device manufacturing environment.
• 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.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 35.00/hr.