Regulatory Affairs Specialist

Spectraforce Technologies; South Portland (ME); On-site; USD 65,000 - 90,000; Full time

Job summary

Spectraforce Technologies, Inc. in South Portland, ME, seeks a Regulatory Affairs Specialist I to support domestic and international product registrations for new and modified medical products within the Infectious Disease unit.

Under general guidance, you will compile submissions, maintain licenses, and help develop internal procedures, ensuring compliance with ISO, FDA, and other regulators. Bachelors in a technical field and 0–2 years regulatory experience preferred; strong MS Office skills

Qualifications

• Bachelor's degree or equivalent in biology, chemistry, biochemistry, engineering or related technical field.
• 0–2 years regulatory experience and/or relevant industrial experience.
• Knowledge of Federal Regulations and regulatory reporting requirements.
• Experience with IVDs and/or biologics regulations is a plus.
• Strong written and verbal communication skills.

Responsibilities

• Compiles and publishes materials for submissions, license renewals, and annual registrations.
• Assists research of scientific/regulatory information to write submission documents.
• Maintains approvals/licenses/authorizations for existing marketing authorizations.
• Ensures compliant shipment of products via updates to inclusions/spreadsheets.
• Adds/updates information in Global Regulatory Information Database.
• Assesses regulatory impact of product, manufacturing and labeling changes.
• Organizes and maintains department files (hard copy and electronic).
• Keeps informed of global regulatory information and trends.
• Assists in developing internal procedures and tools.
• Adheres to company policies and quality systems (ISO, FDA, etc.).
• Represents professional conduct with internal/external associates.

Skills

Regulatory knowledge

Written/verbal communication

Time management

Independent & teamwork

MS Office

Quality Management System (ISO, FDA)

Regulatory compliance (IVDs/biologics)

Education

BS or higher in biology/chemistry/biochemistry/engineering

Bachelor’s degree in technical field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Visio

Job description

Position Title Regulatory Affairs Specialist

Location: South Portland ME

Duration: 12 Months

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 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 Quality Management Systems per ISO, FDA, and other regulatory agencies.
• Was 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
• 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
• 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.