Regulatory Affairs II #1760

About ECIECI'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 ...