Job Description Summary
Job Description
Job Description
Essential Responsibilities:
- Identify, submit and maintain regulatory information in internal Regulatory databases such as RIM, DMS, and PIM.
- Provide regulatory assessment for Change Controls and provide proof of task completion in PEGA system.
- Assess necessity for notification to the Notified Body about significant changes to CE marked products in a timely manner. Prepare documentation updates for non-significant changes in a timely manner.
- Complete, review/approve documentation to ensure regulatory compliance
- Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments as necessary to update Regulatory documentation.
- Submit regulatory information on products to internal and external databases when deemed necessary.
- Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis.
- Coordinate and respond to requests for product data and information
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Qualifications:
Educational Background:
B.S. degree or higher in a technical discipline, preferably in bioengineering, biology, chemistry, computer science, or engineering.
Professional Experience:
3-4 years Regulatory Affairs experience in medical device companies including international product registrations, new product development and sustaining engineering.
Knowledge and Skills:
Knowledge:
- Working knowledge of US regulations for medical device and/or in vitro devices, 21 CFR 820 -Quality System Regulation, relevant standards, and FDA guidance's.
- Working knowledge of EU IVDR/MDR regulations
Skills:
- Proficient in using Microsoft Word, Excel and PowerPoint.
- Proficient in English
- Strong communication Skill, both oral and written
- Strong project management skills
- Must be able to handle multiple tasks and attention to detail.
- Self-motivated, comfortable with working with people remotely
Organized, analytical thinker with attention to details
Required Skills
Optional Skills
.
Primary Work Location
IND Bengaluru - Technology Campus
Additional Locations
Work Shift