Regulatory Affairs Specialist

Must Have – Minimum Requirements

         ·         B Pharm / M Pharm / Bachelor or Master Degree in Bio-Medical Engineering / Science discipline with training in Regulatory Affairs

         ·         Must have at least 4-6 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, Sri Lanka, Bangladesh & Nepal 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.

      Nice to Have

·         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

·         Outgoing and friendly:  Enthusiastic, energetic, diplomatic, willingness to learn

·         Be able to plan, manage, organize and report in an efficient way

·     Be independent, persuasive, innovative and able to summarize

·      Good time management:  Well organized, able to set and reset priorities

         PHYSICAL REQUIREMENTS:

         
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.

·    ABOUT MEDTRONIC

 Together, we can change healthcare worldwide.  At Medtronic, we push the limits of what technology 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 can 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.  Help us shape the future.