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Regulatory Affairs Engineer

Location icon Hyderabad

Location iconJob Posted: December 12, 2024

Location iconExperience: 3-6(years)

Location iconJob Type: Permanent

Location iconQualifications: B.Tech / B.E any discipline.

About iLenSys:

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.

Job Summary:

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
Essential Skill set:
  • 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.
Desirable Skill set:
  • 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.

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iLenSys Technologies Pvt. Ltd.

8-2-293/82/L/231/ABC,
MLA Colony, Road No: 12, Banjara Hills,
Hyderabad, Telangana 500 034
Phone: 040 – 66998246, 040 – 66998234
Email: info@ilensys.com