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17 days old

Regulatory Affairs Specialist

Medtronic
Hyderabad, TS 500001
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Regulatory Affairs Specialist

Location:

Hyderabad, Andhra Pradesh, India

Requisition #:

19000DDJ

Post Date:

Aug 01, 2019


**Careers that Change Lives**


The
position is responsible for supporting projects, communications and submissions
to government agencies to achieve clearances/approvals. This involves
interfacing and supporting requests for information from government agencies.


The
position is responsible for supporting Design and Development Control
activities with regulatory requirements, direction, tactics and strategies and
working in a team environment with all organizational departments.


**A Day in the Life**


Responsible for supporting the needs of the MEIC with regulatory support
for research and development activities and ensuring Indian and other
applicable regulations and policies are met.


**Must Have**


**Job Responsibilities**


+ Prepare,review, file, and support premarket documents for global registrations forassigned projects.

+ Collaboratewith business unit and international regulatory affairs personnel tosupport marketing authorizations for assigned projects.

+ RepresentRegulatory Affairs as team member of product development projects fromConcept through Commercialization.

+ Reviewpre-clinical, and clinical protocols and associated reports to be used insubmissions for assigned projects.

+ DevelopRegulatory Strategies for new or modified products for assigned projects.

+ Monitorand provide information pertaining to impact of changes in the regulatoryenvironment.

+ Communicatewith regulatory agencies and/or notify bodies on administrative androutine matters.

+ Document,consolidate, and maintain oral and written communication with healthauthorities

+ Prepareinternal documents for modifications to devices, when appropriate.

+ Participatein health agency inspections notified body audits as necessary.

+ Authorand/or review regulatory procedures and update as necessary.

+ Reviewchange control documents and ascertain regulatory impact for external andinternal documents through formal regulatory assessments.

+ Assistin development/maintenance of regulatory files, records, and reportingsystems of systematic retrieval of information.

+ Reviewpromotional material, advertising, and labeling to ensure regulatorycompliance on assigned projects.

+ Ensure compliance toregulations specific to clearance and approvals of MEIC developed products rawmaterial and/or prototype.


**Minimum Requirements**


+ 4+years experiences for RA role in medical device or pharmaceutical industry

+ Bachelor degree inMedical, Mechanical, Electric Life Science or other healthcare relatedmajors


**Nice to Have**


+ 4+years experiences for RA role in medical device or pharmaceutical industry

+ Bachelor degree inMedical, Mechanical, Electric Life Science or other healthcare relatedmajors


**About Medtronic**


Together, we can change healthcare worldwide. 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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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Posted: 2019-08-06 Expires: 2019-09-13
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Regulatory Affairs Specialist

Medtronic
Hyderabad, TS 500001

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