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.
