Regulatory Affairs Medical Device jobs
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- Natus SensoryBengaluru, Karnataka
- Health insurance
- Paid time off
- Work from home
- Natus Sensory India are a leading manufacturer of medical devices and software for a range of solutions, including eight sensory nervous systems.
- View all Natus Sensory jobs - Bengaluru, Karnataka jobs
- Salary Search: Regulatory Affairs Specialist salaries in Bengaluru, Karnataka
- ParexelRemote
- Working knowledge of EU and US regulatory procedures, including post-approval requirements.
- Strong understanding of regulatory frameworks, including regional…
- FreelancingLower Parel, Mumbai, Maharashtra
- Health insurance
- Life insurance
- Provident Fund
- Regulatory affairs : 1 year (Required).
- Strong Knowledge of FDA, FOSCOS, WHO, and international registration Process.
- Vincit Labs PVT LTdDelhi, Delhi
- Experience in interacting with regulatory authorities and managing regulatory inspections and audits.
- Strong knowledge of regulatory affairs principles,…
- Tacticity AdvisorsBaner, Pune, Maharashtra
- Health insurance
- Flexible schedule
- 2–4 years of experience in U.S. FDA medical device regulatory affairs, required.
- Strong written communication skills, comfortable producing clear, precise…
- sarah visionLower Parel, Mumbai, Maharashtra
- Lifecycle Management: Monitor post-approval supplements and address regulatory agency queries.
- Compliance: Ensure all research, development, and commercial…
- sarah visionLower Parel, Mumbai, Maharashtra
- Lifecycle Management: Monitor post-approval supplements and address regulatory agency queries.
- Compliance: Ensure all research, development, and commercial…
- Silmed ScientificKochi, Kerala
- Literature search and regulatory evaluation.
- We are hiring an experienced medical writer with experience in CTD medical writing and experience in clinical…
- Neo Sense Vector Technology Pvt LtdAhmedabad, Gujarat
- The QMS Engineer establishes, maintains, and audits the Quality Management System (QMS) for Class II medical devices.
- RegeneronHyderabad, Telangana
- Health insurance
- Paid time off
- Life insurance
- Experience working with Veeva Vault and regulatory document management systems preferred.
- Maintain safety variation trackers, labeling compliance trackers, and…
- grecian pvrt ltdRai, Haryana
- Maintain regulatory records, databases and documentation.
- Respond to regulatory queries and maintain authority communication.
- Genpact India Pvt. Ltd.Hyderabad, Telangana
- Provide regulatory requirements and regulatory strategy to relevant interfaces.
- Provide of regulatory evaluation of change control (affected countries, data/…
- Zydus GroupAhmedabad, Gujarat
- Interact, develop and maintain relationships with regulatory / drug control authorities /government agencies and other external regulatory experts.
- DätwylerUnknown, Maharashtra
- Provide regulatory support to Datwyler employees and customers.
- Participate in different internal projects for regulatory support.
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- ZEISS GroupBengaluru, Karnataka
- 3–5 years of experience in Regulatory Affairs for medical devices.
- Support post-market regulatory activities, including responses to regulatory authorities and…
- View all ZEISS Group jobs - Bengaluru, Karnataka jobs
- Salary Search: Regulatory Affairs Specialist salaries in Bengaluru, Karnataka
- See popular questions & answers about ZEISS Group
- DDReg PharmaGurugram, Haryana
- Perform preliminary quality checks on regulatory and medical writing documents to ensure accuracy, formatting consistency, and alignment with regulatory…
- View all DDReg Pharma jobs - Gurugram, Haryana jobs
- Salary Search: Regulatory_ Medical Writing salaries
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Job Post Details
Regulatory Affairs Specialist - job post
3.53.5 out of 5 stars
Bengaluru, Karnataka•Remote
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Job details
Job type
- Full-time
Benefits
Pulled from the full job description
- Health insurance
- Paid time off
- Work from home
Full job description
Welcome to Natus Sensory India
We are continuing to grow our business in India and are now looking to expand our team there. Be part of this exciting journey right from the start!
Natus Sensory India are a leading manufacturer of medical devices and software for a range of solutions, including eight sensory nervous systems. Our mission is to improve patient outcomes in target markets through innovative screening, diagnostic and treatment solutions. We manufacture and distribute a range of medical device products used in the diagnosis of human disorders of sensory system and neural pathways.
Job Function: Quality Assurance & Regulatory
Job Family: Regulatory Affairs
Job Overview:
Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications.
Responsibilities:
This entry-level professional role is focused on learning to apply formal training and foundational professional concepts to assigned tasks. The position involves gaining familiarity with standard problem-solving methodologies and learning to recognize and escalate issues or abnormalities to more experienced staff before acting on solutions.
The role requires clear and effective communication with coworkers, as well as active listening and the ability to provide factual responses. Project assignments are typically defined by others, and work is reviewed frequently to ensure alignment with expectations.
While independent responsibility is minimal, the individual is expected to contribute as a member of a team and begin developing basic work planning skills. Timely communication with leadership regarding potential delays or issues is essential. This role is designed to provide foundational experience and support professional growth in a structured environment.
Contribute to the team's success by embracing our guiding principles and behaviors and actively participating in a culture that puts our Patient first. You will demonstrate exceptional teamwork, agility, accountability, and respect, cultivating an environment where collaboration and continuous improvement thrive.
Experience Required:
This level is intended for individuals beginning their professional careers or transitioning into a new field. Candidates are expected to have recently completed formal education or training relevant to the role. No or limited prior professional experience may be required, though internships or academic projects may be beneficial. The role focuses on learning core concepts, following structured guidance, and developing the skills needed to perform assigned tasks reliably with support and oversight.
Compensation and Benefits: Along with a competitive salary and performance-based incentives, we offer a comprehensive benefits package starting from day one, including medical insurance coverage for employees and their families, gratuity as per statutory norms, and paid time off in accordance with applicable labor laws.
Join Natus Sensory today. Confidence in every Sense.
We offer:
Natus Sensory is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.
We are continuing to grow our business in India and are now looking to expand our team there. Be part of this exciting journey right from the start!
Natus Sensory India are a leading manufacturer of medical devices and software for a range of solutions, including eight sensory nervous systems. Our mission is to improve patient outcomes in target markets through innovative screening, diagnostic and treatment solutions. We manufacture and distribute a range of medical device products used in the diagnosis of human disorders of sensory system and neural pathways.
Job Function: Quality Assurance & Regulatory
Job Family: Regulatory Affairs
Job Overview:
Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications.
Responsibilities:
This entry-level professional role is focused on learning to apply formal training and foundational professional concepts to assigned tasks. The position involves gaining familiarity with standard problem-solving methodologies and learning to recognize and escalate issues or abnormalities to more experienced staff before acting on solutions.
The role requires clear and effective communication with coworkers, as well as active listening and the ability to provide factual responses. Project assignments are typically defined by others, and work is reviewed frequently to ensure alignment with expectations.
While independent responsibility is minimal, the individual is expected to contribute as a member of a team and begin developing basic work planning skills. Timely communication with leadership regarding potential delays or issues is essential. This role is designed to provide foundational experience and support professional growth in a structured environment.
Contribute to the team's success by embracing our guiding principles and behaviors and actively participating in a culture that puts our Patient first. You will demonstrate exceptional teamwork, agility, accountability, and respect, cultivating an environment where collaboration and continuous improvement thrive.
Experience Required:
This level is intended for individuals beginning their professional careers or transitioning into a new field. Candidates are expected to have recently completed formal education or training relevant to the role. No or limited prior professional experience may be required, though internships or academic projects may be beneficial. The role focuses on learning core concepts, following structured guidance, and developing the skills needed to perform assigned tasks reliably with support and oversight.
Compensation and Benefits: Along with a competitive salary and performance-based incentives, we offer a comprehensive benefits package starting from day one, including medical insurance coverage for employees and their families, gratuity as per statutory norms, and paid time off in accordance with applicable labor laws.
Join Natus Sensory today. Confidence in every Sense.
We offer:
- The role will start as a work-from-home remote position but will turn into a physical presence in an office role in Bangalore.
- Minimal travelling: less than 5%
- Collaborative and international environment with different cultures.
- English company language.
- Full ownership of testing of features and functionality.
Natus Sensory is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.
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