Regulatory Specialist I

Title: Regulatory Specialist I

Location: South Portland, ME

Duration: 12 Months

Shift: 8AM TO 4:30PM

100% Onsite

Qualifications:

• 0-2 years regulatory experience and/or relevant industrial experience typically with a quality, product-development/support, or scientific affairs function.
• Bachelor’s Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience. 
• Knowledge of regulations and standards affecting IVDs and/or biologics.

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 specialist 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, 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.

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, etc.
• 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 Abbott Quality Management Systems 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.

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.