Regulatory Affairs II

About ECI
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

\What You'll Do

• Generate regulatory documentation to be submitted to regulatory agencies in order to secure approvals to market products.
• Submission and Compliance Tracking
• Log Product registrations
• Review GUDID and Country Registrations
• Support RIM database Management
• Prepare and coordinate activities for 510k/De Novo/IDE/PMA (US) and Technical Files/ Design Dossiers (EU) submissions for medical devices.
• Communicates with and maintain productive, constructive relationships with external customers as required – US FDA, notified-bodies, Health Canada, and in-country regulatory representatives.
• Participates in the review and disposition of labeling, promotional material and product modifications for compliance with FDA submissions and applicable regulations.
• Supporting basic and advanced market entrance, providing acquisition due diligence, UDIs, and clinical evaluation reporting (CERs)
• Supports regulatory compliance activities, including processing of complaints and submitting Medical Device Reports and Vigilance Reports
• Assists in CE Marking activities, including preparation of Clinical Evaluation Reports, Technical Files and Design Dossiers
• Represents regulatory function on cross-functional product development and manufacturing support teams. Guide teams to provide content for US and/or International submissions, participates in design reviews as needed.
• Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects.
• Supports engineering changes through RA/QA practices by documenting the changes in compliance with the Quality Systems Regulations.
• Support Post Market Surveillance activities such as CAPA support, post market risk management, recalls, and complaint handling.
• Responsible for FDA/ISO/MDD/CMDR compliance documentation.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
• Interact with European Authorized Representative
• Interact with country regulatory authorities as needed
• Assists in special projects as needed.
• Contributes to team effort by accomplishing related duties as requested.

What We Look For

• Bachelor’s Degree in Engineering, Science or Regulatory affairs is preferred.
• Minimum of 3-5 years experience in Regulatory Affairs in medical device industry preferred.
• Experience with 510k Submission of Class II Medical devices
• Understanding of FDA Regulations, International Regulations and Standards (21 CFR 820, ISO 13485, EUMDR, ISO 14971, ISO 62366, IEC 60601 standard suites, etc.)
• Knowledge of 510k (US) and Technical Files/ Design Dossiers (EU) submissions for medical devices
• Knowledge of defined development process that is consistent with ISO, FDA design control standards or requirements. Knowledge of contemporary design control and risk management practices.
• Demonstrated ability to select, organize, lead, participate, and facilitate a team to produce results.
• Ability to multi-task, handling a number of projects simultaneously, in a fast-paced environment.
• Excellent analytical, troubleshooting, decision making, organizational, time management and communication skills.
• Ability to represent Regulatory Affairs to other departments. RAC certification highly desirable.

ECI is an equal opportunity employer.
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.