Medtronic
Regulatory Affairs Specialist B Pharm / M Pharm / Bachelor or Master Degree in
Bio-Medical Engineering / Science
Main
Purpose:
Responsible
for implementation of regulatory compliance systems and support Regulatory
Affairs activities of India Medtronic. He/she participates in all activities
relating to preparation, submission and follow up to obtain approvals/renewals
for products and its variations & line extension indications and labeling
approvals of medical devices of various business units of Medtronic. He/ she
will be responsible for providing technical support by interpreting federal and
local regulations as they apply to products, processes, practices and
procedures.
Key
Accountabilities:
Manage,
plan and execute the preparation, review and submission of dossiers for product
registrations, import licenses and other approvals from regulatory agencies
(registrations and renewals) thereby supporting the business units and supply
chain management in compliance with regulatory requirements in the Indian
Sub-Continent (India, Sri Lanka, Bangladesh, Nepal)
Coordination
with global regulatory teams, local BU & other functions, for regulatory
strategies and all documentation support required for regulatory submissions in
Indian Sub-Continent.
Submit
and track registration/re-registration applications with the authorities.
Liaise
with product divisions and obtain relevant details for filing changes to the
approved products/licenses.
Assess
the Change controls from the product divisions through post approval change
management and continuously ensure regulatory compliance (reporting of adverse
events/field actions, etc.).
Understanding
& interpretation of law & the local regulatory requirement and
implementing same in submission with compliance.
Close
monitoring of any changes in local & global regulations and communicating
same within the department and respecting & following all SOP / system
implemented within the department and organization.
Ensure
business continuity through regulatory filings, obtaining regulatory approvals
and continuously ensuring regulatory compliance. Also ensure continuous implementation of the
Quality Management System in India.
Supporting
the Marketing Teams on Tender related issues
Development,
implementation and maintenance of regulatory systems pertaining to regulatory
document management (SOP's, archival, trackers and systems) within the department
and organization.
Interface
and coordinate with regulatory agencies/competent authorities (CDSCO, CDDA,
DGDA, State FDA, DoT, AERB, etc.) with respect to submissions, obtaining
registrations/licenses, amendments, regulatory compliance, packaging, quality control
testing or release, etc.
Work
with clinical team on submission and approval of clinical trials applications
(clinical trial approvals, import licenses/test licenses for clinical trial,
amendments, etc.) from various regulatory agencies in the Indian Sub-Continent
Qualifications
& Experience:
B
Pharm / M Pharm / Bachelor or Master Degree in Bio-Medical Engineering /
Science discipline with training in Regulatory Affairs
Must
have at least 5-7 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
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