We are looking for Regulatory Affairs Specialist for our client in Portland, ME
Job Title: Regulatory Affairs Specialist
Job Location: Portland, ME
Job Type: Contract
Pay Range: $25.35hr - $30.35hr
Job Overview:
The position of Regulatory Affairs Specialist I is within the Infectious Disease business unit located in Scarborough, Maine. In this role, under general guidance, the candidate will perform a variety of functions in support of domestic and international product registrations for new and modified products.
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, and related documents.
- 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.
- Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the organization and is consistent with 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.
- Knowledge of Quality Management Systems 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 role.
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 specialists 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, and 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.
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Benefits
Our Benefits Include:
- Medical, Dental, and Vision Insurance
- 401(k) Retirement Plan
- Health Savings Account (HSA)
- Disability Insurance (Short-Term and Long-Term)
- Life and AD&D Insurance
- Paid Sick Leave (where required by applicable state or local law)
- Supplemental Insurance Plans
- Identity Theft Protection
- Pet Insurance
- Employee Wellness Programs
- Employee Assistance Program (EAP)
- Career Growth and Professional Development Opportunities
Disclaimer: Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.
About Cynet Systems
Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.
As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.
