ERT Regulatory Affairs Specialist (Imaging) in Maryland Heights, Missouri
ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that customers can move ahead with confidence. With nearly 50 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so we can adapt without compromising standards.
Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2014, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions in 10,000+ studies spanning more than three million patients to date. By identifying trial risks before they become problems, ERT enables customers to
ERT is hiring a Regulatory Affairs Specialist for our Imaging Department. In this role you will be responsible for compliance with established GMP/ISO quality management system requirements in the development projects. Will work closely with Product Management, Research & Development, Marketing, and Testing Teams to build-in, establish and ensure compliance with local and international regulatory regulations during the Design Projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Proactively develops and implements regulatory documentation and procedures to maintain compliance with FDA 21 CFR 820, ISO 13485, and international medical device regulations during the Design Projects.
Supports and provides regulatory expertise to assigned product development projects from technical approach to post marketing phase.
Provide and Review Development Documentation created during the Design Projects and ensure compliance to Regulatory Standards and Guidelines.
Supports the creation of Regulatory Strategies and Plans for the Design Projects in the domestic and international markets, including assessments of the regulatory impact of changes to design, materials, labeling, software, and suppliers.
Supports the preparation and submission of 510(k)s and other product submissions according to FDA and country specific guidelines.
Supports the development of European Technical File and Declaration of Conformity documents (MDD, RoHS, etc.) and Canadian licensing submissions according to international guidelines.
Reviews and edits product labeling plans, labeling, and marketing communications.
OTHER DUTIES AND RESPONSIBILITIES:
Team member supporting the revision of various regulatory and quality compliance SOPs and work instructions to ensure compliance with local and international regulation.
Part of inter-disciplinary team defining Design Project and Validation activities throughout the product lifecycle and internal processes.
Prepare and submit Medical Device Reports (MDR's) and EU Vigilance reports to the FDA and international regulatory bodies.
Participate in the data analysis for post market surveillance activities.
Assist in the development, maintenance, and implementation of CE Technical Files in accordance with the Medical Device Directive (MDD).
Assist with international regulatory product registrations.
The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. This job description and any attachments do not constitute or represent a contract.
QUALIFICATIONS AND SKILLS NEEDED:
or equivalent in Engineering, Life sciences, or other similar technical field is required. Master’s degree preferred.
2-4 years of experience working with Medical Devices especially in Design Projects.
Experience in the Medical Device industry strongly preferred, may consider other FDA regulated industry.
Excellent analytical, organizational and communication (English language) skills
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Hours: Mon-Fri- 9-5
External Company Name: eResearch Technology
External Company URL: www.ert.com
Street: 77 Progress Parkway