George Philips was established in 1995 and today, is one of India's leading manufacturer and supplier of 'Life Saving Medical Devices and Disposables' to the healthcare industry, both domestically and internationally. The Company was formed by a group of Professional Doctors to cater to the needs of the global healthcare industry for critical care products. The company enjoys a high Brand Equity and all its products are well accepted throughout major hospitals, globally.
Job Title : Engineer - Quality Assurance
Job Description :
- Represent or lead the RA function on assigned cross-functional project teams.
- Develop and execute regulatory plans for the Critical Care product portfolio, including new products and maintenance of licenses/authorizations for existing marketing authorizations.
- Monitor applicable regulatory requirements; assure compliance with external standards.
- Develop and document sound regulatory decisions and justifications.
- Ensure project teams and business objectives and deliverables are aligned with regulatory strategy.
- Review promotional material or SOPs for compliance with local and global regulations.
- Support product owner in assembly of process/product regulatory submission and assist in follow up questions.
- Perform gap analysis and propose solutions.
- Support in GMP or pre-licensing inspections conducted by authorities.
Desired Profile :
Education :B.Tech / M. Tech / M. Sc Biochemistry, Biotechnology, Microbiology
Experience : 1 - 3 years
Skills and Abilities :
- Should have experience working in medical device industry
- Experience in medical device listing / establishment registration / ISO Documentation / medical device reporting
- Understanding of international regulatory requirements for medical devices.
- Proven track record in writing regulatory device submissions
- Strong oral and written communication skills
- Ability to successfully manage projects to deadlines
How to Apply :
Interested candidates can send their resumes to hrd@georgephilips.com
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