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.