ADIUVO DIAGNOSTICS PVT jobs - Regulatory Affairs Specialist

Job Summary
This position is responsible for the preparation of regulatory submissions required to market medical devices in accordance with the European Medical Device Regulation (MDR),and related regulatory affairs activities, such as development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business. Requires the analysis of data, problem solving analysis and in depth evaluations of various factors. May provide leadership by assigning work and resolving complex problems.

Responsibilities and Duties

Coordinate, prepare, and follow up with EU Notified Body in a timely manner. Act as liaison with EU Notified Bodies regarding product approvals. Prepare technical files for CE marking with appropriate input/help from various functions (R&D, Quality, Manufacturing, etc.) in a timely manner. Submit notification to the Notified Body about significant changes to CE marked products in a timely manner. Review/approve labeling to ensure regulatory compliance with the EU Medical Device Regulation. Reviews clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance. Represent RA in product life cycle development teams by reviewing, approving, and completing requirements. Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary Represent RA in design teams and projects by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions. Responsible for writing and updating standard operating procedures (SOP),work instructions (WI),and policies on an as-needed basis. Coordinate and respond to requests for product data/information, surveys/questionnaires required to ensure compliance to the EU Medical Device Regulation.

Key Skills
B.S or BA - Technical disciple preferred , Prior experience in EU Medical Device Directive

Required Experience and Qualifications

• B.S. or B.A. degree in a technical discipline (e.g., engineering, biology, chemistry).
• 1-3 years Medical Device RA Experience or equivalent function (i.e. QA). Preferred experience working with EU Medical Device Directive.