Regulatory Affairs Officer

4 days ago

Mira Road Mumbai Maharashtra, India Vimek Bioconcept Pvt LTd Full time

A regulatory affairs (RA) professional in the in vitro diagnostics (IVD) industry typically has responsibilities that include:

- **Developing regulatory strategies**: Creating and implementing global regulatory strategies for IVD products
- **Reviewing submissions**: Reviewing and revising submissions to regulatory agencies
- **Managing change control**: Ensuring products and change control comply with regulations and company policies
- **Developing policies and procedures**: Creating and implementing policies and procedures within the regulatory affairs department
- **Collaborating with stakeholders**: Working with internal and external partners, including regulatory affairs, medical affairs, and commercial organizations
- **Providing regulatory support**: Providing regulatory writing, submission, and operational support
- **Leading regulatory projects**: Leading or working on regulatory projects to ensure timely completion and issue identification

Some skills and experience that are often required for an RA role in the IVD industry include:

- Experience with IVD medical devices
- Excellent communication and collaboration skills
- Working knowledge of regulations, standards, and guidelines
- A bachelor's degree

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

Pay: ₹100,000.00 - ₹250,000.00 per year

Schedule:

- Day shift

**Experience**:

- total work: 2 years (preferred)

Work Location: In person

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