Labelling Executive

2 weeks ago

Ahmedabad Gujarat, India KK HR services Full time

Key Responsibilities:

- Develop and maintain medical device labels artwork in compliance with applicable regulatory requirements.
- Ensure labelling content aligns with ISO 15223 (Symbols to be used with medical device labels, labelling and information to be supplied).
- Collaborate with cross-functional teams including Regulatory Affairs, Quality Assurance, R&D, and Marketing to gather and validate labelling information.
- Review labelling changes and provide regulatory input during product development and product updates.
- Ensure labels comply with regional regulations such as MDR (EU), FDA (US), and other relevant markets.
- Maintain labelling documentation and change control records in accordance with internal procedures.
- Monitor updates to labelling standards and regulations and assess their impact on existing labelling.

**Qualifications and Requirements**:

- Bachelor's degree in a scientific, engineering, or healthcare-related discipline.
- Minimum 2 years of experience in a regulated medical device environment, preferably in labelling or regulatory affairs.
- Strong knowledge of ISO 15223 and other applicable standards (e.g., ISO 20417, IEC 60601, UDI regulations).
- Familiarity with regulatory requirements for labelling under EU MDR, US FDA, and other global regulations.
- Experience with labelling software tools (CorelDraw, Adobe Illustrator or similar tools) and document control systems is a plus.
- Excellent written and verbal communication skills.
- High attention to detail and ability to work independently and in teams.

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

Pay: ₹18,000.00 - ₹25,000.00 per month

**Benefits**:

- Commuter assistance
- Provident Fund

Schedule:

- Day shift

Work Location: In person

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