Regulatory Specialist I

Abbott; South Portland (ME); Sur place; USD 65 000 - 85 000; Plein temps

Avantages offerts par ce poste

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account (for High-Dedut

Flexible Spending Accounts (Health, LP

Supplemental Life Insurance

Short Term Disability (coverage varies

Long Term Disability

Critical Illness, Hospital coverage, 3

MetLife Legal, MetLife ID Fraud, and

401(k)

Résumé du poste

Abbott is a global healthcare leader seeking a Regulatory Specialist I for the South Portland, ME site. This 12-month, 100% onsite role runs 8am–4:30pm and integrates into a quality-focused regulatory team.

You will compile submissions, maintain licenses, and support global regulatory activities to ensure compliance across products, with opportunities to impact multiple regulatory programs. Qualifications include a BS in a technical field, up to 2 years in regulation, and strong MS Office

Qualifications

• Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering or other relatedtechnical field or the equivalent combination of education and experience.
• BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.
• 0-2 years regulatory experience and/or relevant industrial experience typically with a quality, product-development/support, or scientific affairs function

Responsabilités

• 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.

Connaissances

Knowledge of Federal Regulations

Written and verbal communication

Time management

Independent and team work

MS Office (Word, Excel, PowerPoint,Vis

Quality Management System (ISO, FDA)

Formation

Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering or related technical field

BS preferred in biology/chemistry/medical technology or related

Description du poste

Title: Regulatory Specialist I

Location: South Portland, ME

Duration: 12 Months

Shifts: 8am - 4:30pm

100% Onsite

Responsibilities:

• Compiles and publishes all material required for submissions, license renewals, andannual registrations.
• Assists in the research of scientific and regulatory information in order to writesubmission documents.
• Maintains approvals/licenses/authorizations for existing marketing authorizations.
• Ensures compliant shipment of products through the maintenance of applicableinclusions, spreadsheets, etc.
• Adds and maintains information contained in the Global Regulatory InformationDatabase.
• Assesses product, manufacturing and labeling changes for regulatory reporting impactand 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/external business associates that reflects positively on the company and is consistent with the company'spolicies and practices.

Education:

• Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering or other relatedtechnical field or the equivalent combination of education and experience.
• BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.

Competencies:

• Knowledge of Federal Regulations
• Demonstrated written and verbal communication skills
• Strong time management skills, with the ability to work on multiple projectssimultaneously
• Ability to work independently as well as within a team
• Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio
• Quality Management System per ISO, FDA, and other regulatory agencies.

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

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.

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.