Regulatory Affairs (Medical Device Lead)- Google
Regulatory Affairs (Medical Device Lead)- Google
Job description
Are you looking for a position that will involve interacting with health authorities, influencing industry policy and working with internal teams to help ensure the safe and compliance adoption of healthcare innovations? Explore this Regulatory Affairs (Medical Device Lead) at Google in Bengaluru, India.
Company Description
Google is a multinational technology firm that offers digital products and services to make information more accessible and to improve everyday lives. Through Google for Health, Google uses its technology, artificial intelligence and research to help drive improved health outcomes and healthcare delivery, and to give relevant health information and tools to individuals and healthcare professionals.
Job Summary
The Senior Medical Device Regulatory Policy Lead post is intended for an experienced regulatory affairs professional who can link new healthcare regulations to product development and commercial strategy. The regulatory affairs executive will collaborate with health authorities, tracking regulatory developments that impact digital health and AI-enabled medical solutions, and represent Google in industry conversations and standards organizations. The regulatory affairs specialist will work collaboratively with clinical, engineering, quality and government affairs departments to help establish regulatory strategies that ensure safe, compliant access to global markets.
Key Responsibilities
Provide support to senior leadership in preparation for key regulatory interactions and coordinate key discussions/meetings with health authorities (e.g., India's Central Drugs Standard Control Organization (CDSCO)).
Monitor and analyze legislative developments, government policies and medical device regulations relevant to digital health, healthcare artificial intelligence and Software as a Medical Device (SaMD).
Represent Google in appropriate industry bodies, regulatory forums, standards bodies, and policy talks to advocate for collaboration and influence healthcare policies.
Drafting policy documents, briefing materials and official responses to consultations or regulatory requests.
Communicating complicated regulatory problems simply and accurately.
Work with clinical, engineering, quality and government affairs teams to make sure that medical device features have the proper clinical evidence and that relevant regulatory standards are satisfied.
Advise and guide senior leadership on regulatory policy issues and assist in aligning regional policy efforts to meet the objectives of international digital health product launches.
Engage with regulatory agencies in a non-product submission context and participate in talks on current approaches to overseeing artificial intelligence in healthcare.
Participate in industry norms and regulatory activities, particularly those related to international standards organizations such as ISO/IEC and AAMI, as appropriate to the position.
Educational Qualification
Master’s degree in Science, Engineering, Software, Law, Public Health, Public Policy or similar discipline.
Candidates with comparable practical experience will also be evaluated.
Professional experience in regulatory matters.
Skills Required
Thorough knowledge of medical device rules, standards and regulatory affairs processes.
Knowledge of Software as a Medical Device (SaMD) frameworks.
Ability to monitor regulatory developments and analyze the impact of digital health goods.
Experience preparing policy briefs and other formal regulatory materials.
Knowledge of Artificial Intelligence in healthcare and digital health policy.
Ability to interface with government authorities and articulate regulatory perspectives effectively.
Excellent team skills to work with clinical, engineering, quality and government affairs teams.
Ability to link regulatory requirements to product strategy and market access objectives.
Experience of participation in industry forums, regulatory talks or standards organizations.
Familiarity with generative AI models and their possible applications in clinical settings is a plus.
Salary Structure
The estimated salary of a Regulatory Affairs (Medical Device Lead) at Google in India is between ₹15 Lakhs - ₹18 Lakhs per year.
Career Development
This role offers the opportunity to learn more about medical device regulation, digital health policy, and healthcare AI. This post offers an opportunity to collaborate with senior leadership and regulatory bodies, whilst contributing to policies that influence the development and acceptance of healthcare innovations.
How to Apply
Go to our job portal and look for Regulatory Affairs (Medical Device Lead)- Google.
Open the concerned advertisement and read the full job description and eligibility conditions.
Complete the information required and attach your current resume.
Review your application carefully and submit it through the official careers portal.
Education
Postgraduate Degree (Master's/PhD)
Key Skills
Market insights & trends
Salary Insights
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Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.