Regulatory Affairs Engineer

iLenSys is a global professional services company with leading capabilities in digital technology service. Combining unmatched experience and specialized skills various industries, We are a trusted Digital Engineering and Enterprise Modernization partner, combining deep technical expertise and industry experience to help our clients anticipate what s next. we offerings Technology operations services and proven solutions create a unique competitive advantage for our clients by giving them the power to see beyond.

Include dossier preparation, on-time tracking of applications and network with regulatory bodies and bring in compliance. Play an active role in a change environment. Supports the ongoing implementation and sustainment of Quality and Regulatory compliance as per local and international rules and regulations.

• Minimum 3-5 years of experience in Medical Device Regulation. Experience with international medical device regulatory approvals and submissions
• Awareness of regulatory agency inspections and Notified Body Audits in an SME role
• Demonstrated knowledge of US FDA, EU MDR, ISO 13485 Quality Management System and ISO 14971 Risk Management for Medical Devices as well as IEC 62304, IEC60601etc.
• Ability to analyze and interpret standards, technical procedures, professional journals and governmental guidance and regulation documents
• Proven experience in new medical device registrations and filings
• Working experience with CDSCO, Notified body and other associations for medical device regulation
• Able to constructively collaborate with cross-functional teams
• Working knowledge of quality assurance methodologies
• Knowledge of commonly-used concepts, practices, and procedures for a full product development life-cycle and Medical Device Quality Management System.
• Support compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained.
• Providing guidance to the team to interpret regulatory requirements for various life-cycle stages of the project
• Drive Good Documentation practices
• Ability to follow instructions, work independently, or function in a team as needed
• Highly organized, process orientated and adherence to standard process.
• Exhibit good leadership across departments and teams.
• Good time management and project management.
• Collaborative and a team player
• Good interpersonal, listening and communication skill

• Hands on experience of managing complete existing product development activities (Namely Cost out, Quality and Product obsolescence) for product-based organizations.
• Good experience on existing product development process and working with remote team.
• Strong in mechanical engineering fundamentals
• Excellent communication skills.
• Minimum of 5~8 years of relevant engineering experience
• Experience in Vendor Qualification, developing Manufacturing Quality plan, Tooling and component qualification Thorough understanding of PPAP process.

• Excellent organizational skills required to manage small and large projects.
• Ability to apply engineering principles and practices in the design, development, and verification of possible solutions
• Ability to develop design concepts and turn into finished/product launch.
• Mechanical design knowledge ranging from component design to system level.
• Knowledge on either one of the below processes

-Value engineering methodologies and how to apply them.

-Quality Project execution and standards such as Risk assessment, Root cause analysis procedures, DFMEA, PFMEA, ISO, etc.

-Obsolescence management

• Knowledge of DFM DFA with respect to ease of manufacture and assembly.
• Oversee testing and analysis of products to determine product performance.
• Knowledge of various fabrication methods for the manufacturing of metal and plastic parts machining, welding, sheet metal fabrication, and injection molding is required.
• Skilled in 3D modeling software (Solid Works) is preferred.