Hybrid Regulatory Affairs Specialist Job at BD – BSc Biology Apply Online

Hybrid Regulatory Affairs Job at BD – BSc Biology Apply Online

International Regulatory Affairs Specialist

Hybrid, Bengaluru, Karnataka

Job ID: R-492566

Responsibilities

Job Description Summary

This position is responsible for the creation, identification, collection, and entry of regulatory affairs information of medical devices. Support related regulatory affairs activities for international regulatory submissions, execution, and management of country registration requests. Requires strong organizational skills, communication, and the ability to manage multiple tasks.

Job Description

Essential Responsibilities:

• Create, submit, and maintain product registration requests for submission.
• Review and approve documents required for submission.
• Maintain up-to-date metrics with product registration requests and submission schedules.
• Track regulations applicable to medical devices in designated countries.
• Collaborate with regional RA teams, using internal systems as applicable, to obtain strategic alignment for submission and schedules for each country.
• Input and maintain data, including licenses and registration records, into internal regulatory databases.
• Ensure communications regarding requests from platform RA teams and regional RA teams are responded to in a timely manner.

Qualifications:

Educational Background:

• B.S. degree or higher in a technical discipline, preferably in computer science, engineering, bioengineering, biology, or chemistry.

Professional Experience:

• 1-3 years of Regulatory Affairs experience in medical device companies, including international product registrations, new product development, and sustaining engineering.

Knowledge and Skills:

Knowledge

• Working knowledge of 510(k) (for both medical devices), MDD 93/42/EEC, and working knowledge of 21 CFR 820 – Quality System.

Skills

• Proficient in using Microsoft Word, Excel, and PowerPoint.
• Proficient in English.
• Strong communication skills, both oral and written.
• Strong project management skills.
• Must be able to handle multiple tasks and pay attention to detail.
• Self-motivated, comfortable working with people remotely.
• Organized, analytical thinker with attention to details.

Primary Work Location: IND Bengaluru – Technology Campus

APPLY ONLINE HERE

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