- Responsible for the creation, identification, collection, and entry of regulatory affairs information for medical devices.
- Support regulatory affairs activities for international submissions, and manage country registration requests.
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 to obtain strategic alignment for submission and schedules for each country.
- Input and maintain data, including licenses and registration records, in internal regulatory databases.
- Ensure timely responses to requests from platform and regional RA teams.
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:
- Working knowledge of 510(k), MDD 93/42/EEC, and 21 CFR 820 (Quality System).
- Proficient in Microsoft Word, Excel, and PowerPoint.
- Proficient in English.
- Strong oral and written communication skills.
- Strong project management skills.
- Ability to handle multiple tasks with attention to detail.
- Self-motivated and comfortable working remotely.
- Organized, analytical thinker with attention to detail.
Primary Work Location:
- IND Bengaluru – Technology Campus