Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist

Job Location: Portland, ME

Job Type: Contract

Pay Range: $25.35hr - $30.35hr

Job Overview:

The position of Regulatory Affairs Specialist I is within the Infectious Disease business unit located in Scarborough, Maine. In this role, under general guidance, the candidate will perform a variety of functions in support of domestic and international product registrations for new and modified products.

Responsibilities:

• Compiles and publishes all material required for submissions, license renewals, and annual registrations.
• Assists in the research of scientific and regulatory information in order to write submission documents.
• Maintains approvals/licenses/authorizations for existing marketing authorizations.
• Ensures compliant shipment of products through the maintenance of applicable inclusions, spreadsheets, and related documents.
• Adds and maintains information contained in the Global Regulatory Information Database.
• Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.
• Organizes and maintains hard copy and electronic department files.
• Keeps informed of global regulatory information.
• Assists in developing internal procedures and tools.
• Carries out duties in compliance with established business policies.
• Demonstrates commitment to the development, implementation, and effectiveness of Quality Management Systems per ISO, FDA, and other regulatory agencies.
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the organization and is consistent with 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.

Competencies:

• Knowledge of Federal 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.
• Proficient with Microsoft Office, including Word, Excel, PowerPoint, and Visio.
• Knowledge of Quality Management Systems per ISO, FDA, and other regulatory agencies.

Exempt/Non Exempt:

Non Exempt.

Years Experience:

0-2 years regulatory experience and/or relevant industrial experience typically with a quality, product-development/support, or scientific affairs role.

Function Skills:

• Knowledge of regulations and standards affecting IVDs and/or biologics.

Education: BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.

Duties:

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Supports manufacturing/operations day-to-day activities for change control.
• Provides consultation/advice to regulatory specialists for change control and product development.
• Provides regulatory direction/interpretation on team activities.
• Interprets and applies regulatory understanding to support of products and teams.
• Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
• Handles regulatory activities involved in documentation, labeling, and field support.
• Applies regulatory and technical knowledge to a wide variety of complex work assignments.
• Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
• Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

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• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities