Regulatory Affairs Specialist
2 weeks ago
About the Job:
As a Regulatory Affairs Manager at TeizoSoft Private Limited, you will play a crucial role in ensuring compliance with global regulatory requirements for medical devices. Your responsibilities will include preparing and reviewing premarket documents, collaborating with international regulatory affairs personnel, and representing the company in product development projects.
Key Responsibilities:
- Prepare, review, and file premarket documents for global registrations
- Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations
- Represent Regulatory Affairs as a team member of product development projects from Concept through Commercialization
Requirements:
- Degree in Medical, Mechanical, Electric Life Science or other healthcare-related majors
- 7+ years of experience in RA roles in medical device and/or pharmaceutical industries
- Good understanding of regulations and policies issued by India, US FDA, and EU, and ability to interpret international regulatory requirements
What We Offer:
- Opportunity to work with a dynamic team in a fast-paced environment
- Competitive salary and benefits package
- Professional growth and development opportunities
How to Apply:
Interested candidates should submit their resumes and cover letters to [insert contact information].
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