Regulatory Affairs Specialist 1

Talentburst,-Inc; South Portland (ME); On-site; USD 55,000 - 70,000; Full time

Job summary

Abbott Rapid Diagnostics, part of Abbott’s Diagnostics family, is seeking a Regulatory Affairs Specialist I for the Infectious Disease unit in Scarborough/South Portland, Maine. You will support domestic and international product registrations for new and modified products while working with a cross-functional team.

Required is a Bachelor's degree in a technical field and knowledge of Federal Regulations, with strong written and verbal communication skills and the ability to manage multiple

Qualifications

• Bachelor’s degree in a technical field or equivalent experience.
• Knowledge of Federal Regulations for medical devices and diagnostics.
• Strong written and verbal communication skills.
• Ability to manage multiple projects with minimal supervision.

Responsibilities

• Compiles and publishes submissions for licenses and renewals.
• Researches regulatory information to support registrations.
• Maintains approvals and supports labeling changes.
• Ensures compliance with ISO, FDA, and other regulatory bodies.
• Prepares U.S. submissions and international documentation.

Skills

Regulatory knowledge

Written communication

Time management

MS Office

Regulatory submissions

Education

Bachelor's in Biology, Chemistry, Biochemistry, Engineering

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Visio

Job description

South Portland ME
Regulatory Specialist I
12 + MONths contract
(1st shift) 8am - 4:30pm

Position Title Regulatory Affairs Specialist I ARDx Business Unit/Function Infectious Disease

Department Regulatory Affairs

Direct Manager Manager, Regulatory Affairs or VP, Regulatory Affairs

Primary Location (Supporting Locations) Scarborough, Maine, South Portland, Maine

Abbott Rapid Diagnostics is part of Abbott’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 I is within our Infectious Disease business unit located at Scarborough, Maine. In this role you will with general guidance, perform a variety of functions in support of domestic and international product registrations for new and modified products.

This job description will be reviewed periodically and is subject to change by management.

RESPONSIBILITIES:

• Compiles and publishes all material required for submissions, license renewals, and
• Assists in the research of scientific and regulatory information in order to write
• Maintains approvals/licenses/authorizations for existing marketing authorizations.
• Ensures compliant shipment of products through the maintenance of applicable
• Adds and maintains information contained in the Global Regulatory Information
• Assesses product, manufacturing and labeling changes for regulatory reporting impact
• 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.

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 Abbott Quality Management System 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 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 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.