Regulatory Affairs Executive

4 days ago

Hyderabad Telangana, India MAJiK Medical Solutions Pvt. Ltd. Full time

**Job Summary**:
**Key Responsibilities**:

- Assist in the preparation and submission of regulatory documents for product registration and approvals (e.g., 510(k), CE Marking, CDSCO).
- Support the creation and maintenance of Technical Files, Design Dossiers, and product master files.
- Coordinate with internal teams (R&D, Quality, Manufacturing) to gather necessary documents for submissions.
- Monitor and interpret changes in global regulatory requirements and ensure compliance.
- Maintain databases and trackers for regulatory submissions, approvals, renewals, and other related activities.
- Assist with responding to queries from regulatory bodies and notified bodies.
- Help ensure that labeling, packaging, and promotional materials comply with applicable regulations.
- Support internal and external audits by providing relevant regulatory documents.
- Collaborate with senior team members to learn best practices and regulatory strategies.

**Requirements**:
**Education**:

- Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related field.

**Experience**:

- 1-2 years of experience in Regulatory Affairs in the medical device or healthcare industry.

**Skills & Knowledge**:

- Basic understanding of medical device regulations such as FDA 21 CFR Part 820, EU MDR 2017/745, or CDSCO.
- Familiarity with ISO 13485 and documentation standards.
- Good written and verbal communication skills.
- Attention to detail and strong organizational abilities.
- Ability to work collaboratively in a cross-functional team environment.
- Proficient in Microsoft Office (Word, Excel, PowerPoint).

**Preferred Qualifications (Optional)**:

- Internship or project experience related to regulatory affairs.
- Exposure to international regulatory submissions.
- Knowledge of risk management principles (e.g., ISO 14971).

**Career Development**:
This position offers excellent learning opportunities and career growth into roles such as **Senior Regulatory Affairs Executive**, **Regulatory Specialist**, or **Regulatory Affairs Manager**

Pay: ₹20,000.00 - ₹38,000.00 per month

**Benefits**:

- Health insurance
- Provident Fund

Work Location: In person

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