Regulatory Specialist I # 26-27363

US Tech Solutions; South Portland (ME); On-site; USD 65,000 - 90,000; Full time

Job summary

US Tech Solutions is seeking a Regulatory Affairs Specialist I for the Infectious Disease unit in Scarborough, Maine. With aBachelor’s degree in science, you’ll support domestic and international product registrations and contribute to regulatory submissions with guidance.

You will compile documents, research regulatory information, maintain licenses, ensure compliant shipping, and assist in procedures aligned with ISO and FDA standards. This is a 12-month position at a global services firm.

Qualifications

• Knowledge of Federal Regulations and regulatory submissions.
• 0-2 years regulatory experience or related industrial exposure.
• Strong written and verbal communication skills; problem solving abilities.

Responsibilities

• Compiles and publishes material for submissions, license renewals and registrations.
• Assists in researching regulatory information to write submission documents.
• Maintains approvals and licenses for existing marketing authorizations.
• Ensures compliant shipment of products and maintains related data.
• Assesses changes for regulatory reporting impact and compliance.
• Organizes department files and stays informed on global regulatory information.
• Participates in developing internal procedures and tools.
• Adheres to ISO, FDA and other regulatory agency requirements.

Skills

Regulatory knowledge

Time management

Independent & team work

Education

Science degree

Tools

Microsoft Office

QMS familiarity

Job description

Duration: 12 Months--Possible extension

Description

The position of Regulatory Affairs Specialist I is within our Infectious Disease business unitlocated at Scarborough, Maine. In this role you will with general guidance, perform a variety offunctions in support of domestic and international product registrations for new and modifiedproducts.

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 Client’s 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.

Basic Qualifications

Education

• Bachelor’s degree in Biology, Chemistry, Biochemistry, Engineering or other relatedtechnical 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 projectssimultaneously
• Ability to work independently as well as within a team
• Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio, Client’s Quality Management System per ISO, FDA, and other regulatory agencies.

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

About US Tech Solutions

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visitwww.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

AI Statement

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