Regulatory Affairs Executive

2 weeks ago

Najafgarh, Delhi, India Genetix Biotech Asia Pvt Ltd Full time

Responsibilities:

Regulatory Compliance:
Stay up-to-date with the latest CDSCO India guidelines and other relevant regulations pertaining to medical devices. Ensure that all products and processes adhere to these guidelines.

Regulatory Strategy:
Develop and implement regulatory strategies for the successful approval and launch of medical devices in India.

Documentation:
Prepare and maintain all documentation required for regulatory submissions, including technical dossiers, product information, labeling, and risk assessments.

Regulatory Intelligence:
Monitor changes in regulations and guidelines and assess their impact on the organization's medical devices.

Regulatory Submissions:
Coordinate and manage the submission process, responding to queries and requests for additional information from regulatory authorities.

Audits and Inspections:
Assist in preparing for and participating in regulatory audits and inspections by authorities.

Qualifications and Skills:

  • Bachelor's or Master's degree in a relevant scientific field.
  • Minimum of 2 years of experience working in Regulatory Affairs for Medical Devices in India, with indepth knowledge of CDSCO guidelines.
  • Familiarity with ISO standards and other international regulatory requirements for medical devices is a plus.
  • Strong understanding of medical device classification and the regulatory approval process in India.
  • Excellent written and verbal communication skills to effectively communicate with regulatory authorities and internal teams.
  • Detailoriented with the ability to review technical documentation and regulatory submissions critically.
  • Ability to work independently and manage multiple projects simultaneously.
  • Problemsolving skills to address regulatory challenges and provide solutions.

Working Conditions:
The Regulatory Affairs Executive for Medical Devices will typically work in an office environment.


Join our team as a Regulatory Affairs Executive for Medical Devices and contribute to ensuring that our products meet all the necessary regulatory requirements for the Indian market.

Your expertise in CDSCO / NSWS India guidelines will play a pivotal role in our success as we bring innovative medical devices to patients and healthcare providers in India.


Salary:
Negotiable

Schedule:

  • Day shift

Job Types:
Full-time, Permanent

Benefits:

  • Health insurance
  • Provident Fund

Schedule:

  • Day shift

Supplemental pay types:

  • Yearly bonus

Experience:

- total work: 1 year (preferred)

Ability to Commute:

  • Najafgarh, Delhi, Delhi (required)

Ability to Relocate:

  • Najafgarh, Delhi, Delhi: Relocate before starting work (required)

Work Location:
In person

Speak with the employer
Application Deadline: 19/02/2024

  • Field Sales Executive

    2 weeks ago

    Najafgarh, Delhi, India Crack-ED Full time

    Overview:Axis Bank is hiring Field Sales Executives to join our team and drive Current Account and Savings Account (CASA) acquisition. This role involves reaching out to potential customers, promoting Axis Bank's CASA products, and meeting sales targets.Responsibilities: Identify and approach potential customers for CASA acquisition. Pitch Axis Bank's CASA...

  • Product Manager

    2 weeks ago

    Najafgarh, Delhi, India StaffSeek Full time

    Job Summary :We are seeking an experienced Product Manager with a strong background in Human Resource Management Systems (HRMS) to join our dynamic team. The ideal candidate will have over 3 years of experience in the HRMS domain and will be responsible for the product lifecycle management from strategic planning to tactical activities.Job Title: Product...

  • Regulatory Affairs Executive

    5 days ago

    Najafgarh, Delhi, Delhi, India Genetix Biotech Asia Pvt Ltd Full time

    **Responsibilities**: Regulatory Compliance: Stay up-to-date with the latest CDSCO India guidelines and other relevant regulations pertaining to medical devices. Ensure that all products and processes adhere to these guidelines. Regulatory Strategy: Develop and implement regulatory strategies for the successful approval and launch of medical devices in...

  • Product Manager

    3 weeks ago

    Najafgarh, India StaffSeek Full time

    Job Summary :We are seeking an experienced Product Manager with a strong background in Human Resource Management Systems (HRMS) to join our dynamic team. The ideal candidate will have over 3 years of experience in the HRMS domain and will be responsible for the product lifecycle management from strategic planning to tactical activities.Job Title: Product...

  • Sampling Coordinator for Corrugation

    4 weeks ago

    Najafgarh, Delhi, Delhi, India packtek packaging Full time

    **Roles and Responsibilities** - Development of primary, secondary, and tertiary packaging and convert them in to KLDs - Providing inputs in the product development stage on the techno-commercial feasibility - Benchmarking of different packaging/competitor products as per market trends - Identify cost savings opportunities by benchmarking competitor...