Labelling Specialist - Medical Device

Job Title: Labelling Specialist - Medical Devices

Location: Sanand, Ahmedabad

Department: Quality Assurance

Employment Type: Full-Time (On-Site)

Reports To: Quality Manager

Job Summary:

We are seeking a detail-oriented and knowledgeable Labelling Specialist to manage the

creation, review, and maintenance of labelling content for our medical devices. The ideal

candidate will have a strong understanding of medical device regulations and be well-versed

in labelling standards, particularly ISO 15223. This role is critical to ensuring our product

labels are compliant, accurate, and aligned with global regulatory requirements.

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

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.