Medtronic Hiring Regulatory Affairs Specialist
Position Name: Regulatory Affairs Specialist-II
Organization: Medtronic
Location: Gurgaon, Haryana
Industry Type: Pharma / Healthcare / Clinical Research
Functional Area: Regulatory Affairs
Experience Required: 5-7 years
Qualifications: B.Pharm / M.Pharm / Bachelor’s or Master’s Degree in Bio-Medical Engineering / Science discipline with training in Regulatory Affairs
Application Deadline: 30th July 2024
Company Overview:
At Medtronic, we strive to push the limits of technology, therapies, and services to alleviate pain, restore health, and extend life. We challenge ourselves to make tomorrow better than yesterday, creating an exciting and rewarding environment for growth and innovation.
Key Responsibilities:
| Responsibility | Details |
|---|---|
| Preparation and Submission | Manage the preparation, review, and submission of dossiers for product registrations, import licenses, and other regulatory approvals. |
| Coordination | Work with global regulatory teams, local business units, and other functions to develop regulatory strategies and documentation. |
| Monitoring and Compliance | Track registration applications, assess change controls, and ensure continuous regulatory compliance. |
| Regulatory Systems | Develop and maintain regulatory systems for document management, including SOPs and archival systems. |
| Agency Liaison | Interface with regulatory agencies such as CDSCO, FDA, CE, and others for submissions, registrations, and compliance. |
Candidate Profile:
| Profile Attribute | Details |
|---|---|
| Experience | At least 5-7 years in the pharma/medical device/life science industry, with a minimum of 2-3 years in regulatory affairs specifically related to medical devices. |
| Knowledge | Familiarity with regulatory requirements for India and experience with CDSCO, FDA, CE, and other relevant regulations. |
| Skills | Excellent communication and interpersonal skills, customer-focused, capable of establishing credibility, and effective in time management. |
| Attitude | Self-motivated, enthusiastic, with a positive attitude and the ability to work both independently and as part of a team. |
How to Apply:
To apply, submit your resume and cover letter before the application deadline of 30th July 2024.
Contact:
For more information or to apply, please visit Medtronic’s career page or contact their HR department.
If you need any more details or have questions about the application process, feel free to ask!