At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives.
Post : Regulatory Affairs Specialist
Job Description
A Day in the Life
Responsible for implementation of regulatory compliance systems and support Regulatory Affairs activities of India Medtronic. He/she participates in all activities relating to preparation, submission and follow up to obtain approvals/renewals for products and its variations & line extension indications and labeling approvals of medical devices of various business units of Medtronic. He/ she will be responsible for providing technical support by interpreting federal and local regulations as they apply to products, processes, practices and procedures
Responsibilities may include the following and other duties may be assigned.
• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or 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.
Candidate Profile
• B Pharm / M Pharm / Bachelor or Master Degree in Bio-Medical Engineering / Science discipline with training in Regulatory Affairs
• Must have at least 3-6 years’ experience in the pharma/medical device/life science industry with at least 2-3 years' medical device experience in regulatory affairs
• Conversant with various regulatory requirements for India with respect to medical device registration, import, clinical trials, etc.
• Knowledge in application of CDSCO, FDA, CE and other regulatory requirements especially in the area of Quality Systems and Design Control as applied to projects from design inception to manufacturing release
• Excellent communication and interpersonal skills - Good verbal communicator and presenter
• Customer focused: Understands and delivers customer service
• Ability to quickly establish credibility with all levels of Regulatory Agencies, Government, etc.
• Good verbal and written communication skills in English - with colleagues, management and external authorities
• Self-motivated and positive "Can do" attitude. Can work autonomously but is also a team player
Additional Information
Experience : 3-6 years
Qualification : B.Pharm / M.Pharm
Location : Gurgaon
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 30th January, 2025
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