Regulatory Associate- Medical Device

5 days ago

Thiruvananthapuram, India Genrobotic Innovations Full time

**Job Summary**

As a Regulatory Associate in the Medical Device Industry, you will be responsible for ensuring that the company's medical devices comply with all regulatory requirements.You will work closely with cross-functional teams to ensure that products meet regulatory standards and will be responsible for preparing, submitting and maintaining regulatory documentation. You will also be responsible for monitoring and communicating changes in regulations and standards to ensure compliance.

**Responsibilities**
- You will be responsible for ensuring compliance with all applicable regulations including Drug License, FDA, ISO, and other national and international regulations.
- You will be responsible for preparing and submitting regulatory documentation for new and existing medical devices, including MDR: 2017 submissions, 510(k)submissions, technical files, and other regulatory documents.
- You will assist in the development of regulatory strategies to support the company's product development goals.
- You will communicate with regulatory agencies as necessary, and will keep cross-functional teams informed of regulatory requirements and changes.
- You will monitor changes in regulations and standards, and will work with cross-functional teams to ensure compliance with new requirements.
- You will assist in preparing for and participating in regulatory compliance audits.
- You will assist in maintaining the company's quality system, including documentation control and management.
- You will be responsible for adverse event reporting as required by regulatory agencies.

**Qualification**:Bachelor’s degree in a scientific or technical discipline (biomedical
engineering, other engineering decipline)

**Additional Qualification**: Biomedical engineer

**Experience **:Minimum 2 years

**Job Location**: Technopark,Thiruvananthapuram

**Job Types**: Full-time, Regular / Permanent

**Salary**: ₹25,000.00 - ₹45,000.00 per month

**Benefits**:

- Provident Fund

Schedule:

- Day shift

Ability to commute/relocate:

- Thiruvananthapuram, Kerala: Reliably commute or planning to relocate before starting work (required)

Application Question(s):

- What is your current monthly salary?
- What is your monthly salary expectation?
- What is your notice period?(Indays)

Work Location: In person

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