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Regulatory Engineer

Location icon Hyderabad

Location iconJob Posted: August 7, 2024

Location iconExperience: 5-9(years)

Location iconJob Type: Permanent

Location iconQualifications: B.E/B.Tech in Electronics/Electrical/Mechanical Engineering

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:

Regulatory Affairs Support: - This position is to manage customer divisional role and supporting both manufactured and OEM products. Regulatory Affairs team is responsible for guidance, facilitating and executing regulatory strategy defined by the divisional Manager of Regulatory Affairs. This position will interact with the OEM Customer’s Regulatory Affairs representatives applicable to the region to support Global submissions and resolve regulatory issues. In addition, this position will ensure adherence to established processes, policies and procedures of the company and external regulatory agencies.

  • Five or more years of working experience in Regulatory/ compliance
  • Should have a detailed knowledge of the applicable standards and regulations that apply to the products (product safety standards like IEC 61010-1, EMC standards EN 61326-1).
  • Should have working experience or a detailed knowledge on medical device classification, country-wise requirements like US FDA, ISO 13485 and EU MDR, etc.
  • Responsible for the coordination, evaluation and implementation of regulatory strategy and compliance programs to fulfill customer business goals in a compliant manner.
  • Supports an effective interface between the respective disciplines and 3rd Party regulatory agencies (UL, CSA, TUV, Notified Bodies, FDA, ISO registrars, etc) and ensures this interaction follows the established best practice model for the division.
  • Provides review, consultation and support for regulatory agency communications for Laboratory and Medical devices on regulatory markings and registration. (e.g. UL/CSA/CE, FDA, EU Competent Authorities, China SFDA, etc).
  • Participates in product reviews and ensures that the RA team provides a compliance review for both internal product designs or changes and OEM products.
  • Must support and help effectively manage any identified non-conformity or product liability discovery or incident as assigned by the RA Support Manager.
  • Provides support to customers relative to compliance issues.
  • Act as a change agent for improvement initiatives
  • Perform all job duties in a safe manner and obey all safety policies and procedures.
  • Perform all job duties within ISO standards, regulatory or statutory requirements
  • Experience with initial regulatory submissions as well as periodic submission of updates (examples include FDA 510(k) submissions, MDD / IVDD Technical Files etc.) a plus.
  • Experience of negotiating requirements with competent authorities or regulatory bodies a plus.
  • Medical Device manufacturing experience preferable.
  • Adaptability and flexibility to manage changing demands and handle substantial time pressures 
  • Solid financial understanding and ability to relate business improvements into relevant financial terms
  • Demonstrated experience in problem solving, particularly around managing a new regulation requirement, or risk assessment around a product liability issue.
  • Job duties may require brief exposure to research laboratory biopharmaceutical or pharmaceutical laboratory equipment.
  • Proven facilitator that effectively coordinates and leads efforts and input from various internal functional groups, which will result in collective team achievements
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