Hybrid Work Opportunity at BD

Hybrid Work Opportunity at BD For Biology Candidates – Apply Online

International Regulatory Affairs Specialist

remote type: Hybrid

locations: IND Bengaluru – Technology Campus

time type: Full time

posted on: Posted Today

job requisition id: R-492566

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 request. Requires strong organizational skills, communication and ability to manage multiple tasks.

Job Description

Essential Responsibilities:

  • Create, submit and maintain product registration request for submission
  • Review and approve documents required for submission
  • Maintain up to date metrics with product registration request and submission schedule
  • Track regulations applicable for 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 request 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 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 attention to detail.
  • Self-motivated, comfortable with working with people remotely
  • Organized, analytical thinker with attention to details

Primary Work Location: IND Bengaluru – Technology Campus

APPLY ONLINE HERE

Keywords: International Regulatory Affairs Specialist, Medical Devices, Regulatory Affairs, Medical Device Companies, Regulatory Submissions, Compliance, Regulations, Remote Work, Bengaluru. Hybrid Work Opportunity at BD For Biology Candidates – Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like TwitterTelegramFacebook and Instagram.

Shekhar
Shekhar Suman is the Co-founder of BioTecNika Info Labs Pvt. Ltd. He is an Entrepreneur, Writer, Public Speaker, and a Motivational Coach. In his career, he has mentored more than 100,000+ students toward success in the Biopharma Industry. He heads the BioTecNika Group, which comprises BioTecNika.com, BioTecNika.org, and Rasayanika.com. An avid reader and listener who is passionate about BioSciences. Today Biotecnika is India's largest Biotech Career portal, with over 5 Million subscribers from academia & Industry. It's ranked among the top 50 websites worldwide in the Biology category.