Regulatory Affairs Executive

4 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 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 in-depth 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.
- Detail-oriented with the ability to review technical documentation and regulatory submissions critically.
- Ability to work independently and manage multiple projects simultaneously.
- Problem-solving 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**

+91 9312737271

Application Deadline: 19/02/2024

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