International Regulatory Affairs Specialist

2 weeks ago


Bengaluru, Karnataka, India BD (Becton, Dickinson and Company) Full time
**Job Description Summary**
Working closely with the Senior International Regulatory Affairs Manager, the International Regulatory Affairs Specialist will be responsible for supporting international regulatory affairs registrations on medical devices and in vitro diagnostic devices across the globe.
**Job Description**
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 task.
**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 licesnse 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:**
3-7 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, MDR 2017/745 and working knowledge of 21 CFR 820 -Quality System.
**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**
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

  • Bengaluru, Karnataka, India Lifelancer Full time

    Job Title: International Regulatory Affairs Specialist Job Location: Bengaluru, Karnataka, India Job Location Type: Hybrid Job Contract Type: Full-time Job Seniority Level: Job Description SummaryWorking closely with the Senior International Regulatory Affairs Manager, the International Regulatory Affairs Specialist will be responsible for supporting...


  • Bengaluru, Karnataka, India BD (Becton, Dickinson and Company) Full time

    **Job Description Summary**Working closely with the Senior International Regulatory Affairs Manager, the International Regulatory Affairs Specialist will be responsible for supporting international regulatory affairs registrations on medical devices and in vitro diagnostic devices across the globe.**Job Description**This position is responsible for the...


  • Bengaluru, Karnataka, India Lifelancer Full time

    Job Title: International Regulatory Affairs Specialist Job Location: Bengaluru, Karnataka, India Job Location Type: Hybrid Job Contract Type: Full-time Job Seniority Level: Job Description SummaryThis position is responsible for the creation, identification, collection and entry of regulatory affairs information of medical devices. Support related...


  • Bengaluru, Karnataka, India Infosys Full time

    Job OverviewWe are seeking an experienced Regulatory Affairs Specialist to join our team at Infosys.The ideal candidate will have a strong background in export control regulations and compliance, with 4-7 years of relevant experience. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with applicable export control...


  • Bengaluru, Karnataka, India BD (Becton, Dickinson and Company) Full time

    **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,...


  • Bengaluru, Karnataka, India Philips Full time

    JOB DESCRIPTION Job Title Senior Regulatory Affairs Specialist Job Description Job Title : Senior Regulatory Affairs Specialist The Sr. Regulatory Affairs Specialist (RA specialist) is responsible for the coordination and preparation of regulatory plans and document packages for regulatory submissions (FDA, Health Canada, EU, Asia, etc). The RA...


  • Bengaluru, Karnataka, India Oracle Full time

    We are a leading provider of healthcare technology solutions, and we are seeking a Regulatory Affairs & Compliance Strategist to join our team at Oracle Health. Our solutions aim to improve patient outcomes and streamline clinical workflows, and we need a dedicated professional to assist us in maintaining our compliance with regulatory requirements.The...


  • Bengaluru, Karnataka, India Biocon Full time

    At Biocon, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role is crucial in ensuring compliance with regulatory requirements and facilitating the development of new molecules.As a Regulatory Affairs Specialist, you will be responsible for DMF compilation and submission to global markets. You will also handle...


  • Bengaluru, Karnataka, India Lifelancer Full time

    Job Title: Regulatory Affairs Specialist Job Location: Bengaluru, Karnataka, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech...


  • Bengaluru, Karnataka, India Philips Full time

    About the RoleThe Senior Regulatory Affairs Manager will lead a team of Regulatory Affairs professionals in developing and deploying innovative, compliant regulatory strategies to grow and sustain the MRI portfolio. This portfolio spans imaging medical systems and software and drives Philips' mission to improve the lives of 2.5 billion people by 2030.This...


  • Bengaluru, Karnataka, India Bionova Lifesciences Full time

    Regulatory Affairs Manager Location: Bangalore Job Type: Full-time Salary: Job Overview:We are seeking a highly skilled Regulatory Affairs Manager to oversee regulatory submissions, ensure compliance with national and international pharmaceutical & FSSAI regulations, and maintain product registrations. The ideal candidate will play a key role in liaising...


  • Bengaluru, Karnataka, India ResMed Full time

    The primary role of the Regulatory Affairs function is to provide support and guidance with respect to regulatory environment, at all stages of the life cycle of ResMed's products. Key deliverables include adding value to business through ensuring compliance and delivery of optimal regulatory strategies for portfolio planning, active regulatory intelligence...


  • Bengaluru, Karnataka, India Biocon Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Biocon. As a key member of our regulatory affairs department, you will be responsible for preparing and reviewing Abbreviated New Drug Applications (ANDAs) for submission to the US market.The successful candidate will have expertise in maintaining control over...


  • Bengaluru, Karnataka, India Biotech Healthcare Full time

    Key ResponsibilitiesThe Regulatory Affairs Specialist - Clinical Trials will oversee clinical trial execution from initiation to close-out, register clinical trials on various regulatory platforms as per local regulations, and ensure timely data collection from sites for ongoing projects.Oversee clinical trial execution from initiation to close-out.Register...


  • Bengaluru, Karnataka, India Lifelancer Full time

    Job Title: Specialist - Regulatory Affairs Manager Job Location: Bengaluru, Karnataka, India Job Location Type: On-site Job Contract Type: Full-time Job Seniority Level: Mid-Senior level Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech,...


  • Bengaluru, Karnataka, India Biocon Full time

    Job DescriptionAbout the Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Biocon. As a key member of our regulatory affairs team, you will be responsible for ensuring that our products meet all necessary regulatory requirements in the US market.Main Responsibilities:Product Submission and Lifecycle Management: Prepare,...


  • Bengaluru, Karnataka, India ClinChoice Full time

    Regulatory Affairs CoordinatorWe are looking for a detail-oriented Regulatory Affairs Coordinator to support our team in ensuring compliance with regulatory requirements. The successful candidate will have experience in raising follow-up queries, managing clinical data in ARGUS database, and ensuring compliance with relevant regulations.Key...


  • Bengaluru, Karnataka, India Lifelancer Full time

    Job Title: Regulatory Affairs Analyst Job Location: Bengaluru, Karnataka, India Job Location Type: Hybrid Job Contract Type: Full-time Job Seniority Level: Job Description SummaryThis position is responsible for the creation, identification, collection and entry of regulatory affairs information of medical devices and in vitro diagnostic devices. Support...


  • Bengaluru, Karnataka, India Lifelancer Full time

    Job Title: Regulatory Affairs Analyst Job Location: Bengaluru, Karnataka, India Job Location Type: Hybrid Job Contract Type: Full-time Job Seniority Level: Job Description SummaryThis position is responsible for the creation, identification, collection and entry of regulatory affairs information of medical devices and in vitro diagnostic devices. Support...


  • Bengaluru, Karnataka, India Philips Full time

    JOB DESCRIPTION Job Title Principal Regulatory Affairs MR Software Job Description Your role: The Principal Regulatory Affairs MR Software (Principal RA) is responsible for the coordination and preparation of regulatory plans and document packages for regulatory submissions (FDA, Health Canada, EU, Asia, etc.). The Principal RA also provides...