09 Sep
|
Apple
|
Gurugram
Imagine what you could do here. At Apple, excellent ideas have a way of becoming
great products, services, and customer experiences. Bring passion and dedication
to your job, and there’s no telling what you could accomplish. The people at
Apple don’t just build products — we craft the kind of wonder that’s
revolutionised entire industries. The Health group is looking for a Principal
Regulatory Affairs Associate to help drive strategy, submissions, and policy for
health products in India and surrounding geographies. If you are passionate
about the health space and want to have an incredible impact here at Apple, this
could be the role for you. We are an efficient team who works closely together
to build relationships across multiple functional teams. We care deeply about
getting amazing new products into our customers hands. We come to Apple to think
creatively about how to launch products within a rigorous regulatory structure
for medical devices.
DESCRIPTION
You will represent the RA/QA team on a diverse array of regulatory submissions
and policy initiatives with the goal of obtaining approvals for new technologies
and making an impact in health policy. You will demonstrate the ability to
develop a variety of solutions to regulatory challenges and will exercise
independent judgment in settling and communicating appropriate regulatory action
and requirements. This role will involve assessment of regulatory impact for current
and modified Class A, B, and C products including identification of
assumptions/risks/mitigations to develop and execute clear regulatory plans in
India and surrounding geographies.
MINIMUM QUALIFICATIONS
Bachelor's in Mechanical/Electrical/Biomedical/Computer Science degree or
equivalent in any engineering discipline 10+ years of medical device experience
in a regulatory role, with at least 5+ years as a principal, manager or lead.
Significant experience in leading interactions with CSDSCO. Significant
experience preparing regulatory filings
📌 India Principal Regulatory Associate (Gurugram)
🏢 Apple
📍 Gurugram