Regulatory Affairs Executive
2 weeks ago
Company Description
GESCO Healthcare is a leading manufacturer and exporter of spinal, orthopaedic, and CMF implants and surgical instruments in the Asia-Pacific region. With over 60 years of experience, GESCO has transformed the lives of over 120 million people. The company's innovation center leads the way in developing path-breaking and cost-effective technology, and has been awarded numerous worldwide patents for its cutting-edge innovation in implants and surgical instruments.
Role Description
This is a full-time on-site role for a Regulatory Affairs Executive in Chennai. The Regulatory Affairs Executive will be responsible for regulatory documentation, ensuring compliance with regulatory requirements, dossier preparation, and other regulatory affairs tasks as assigned.
Maintain Regulatory Files.
Assist in preparing response to Regulatory Authorities' questions with assigned timelines.
Review and create product labels and review promotional materials with applicable regulations and standards.
Conduct Internal Audits
Stay abreast of the response to regulatory authorities questions within the assigned timelines.
Write, analyse and edit technical documents to support country - specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents.
**Skills**:
Immediate joiners preferred
Regulatory Documentation and Regulatory Compliance skills
Strong understanding of Regulatory Requirements
Experience with Dossier Preparation
Familiarity with Regulatory Affairs
Strong analytical and problem-solving skills
Excellent written and verbal communication skills
Attention to detail and ability to work independently
Bachelor's or Master's degree in Life Sciences, or related field.
Minimum of 2 years of experience in regulatory affairs in medical devices.
Knowledge of medical device regulations in different countries and regions is a plus.
Familiarity with 21CFR 820, ISO 13485, EU MDR 2017 and Indian Medical Device Rules.
Familiarity with QMS documentation handling.
Strong command over English.
**Job Types**: Full-time, Permanent
**Salary**: ₹20,000.00 - ₹30,000.00 per month
**Benefits**:
- Provident Fund
Schedule:
- Day shift
Supplemental pay types:
- Yearly bonus
Ability to commute/relocate:
- Ambattur, Chennai, Tamil Nadu: Reliably commute or planning to relocate before starting work (required)
**Experience**:
- total work: 2 years (preferred)
Work Location: In person
**Speak with the employer**
+91 8754563607
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