Job Description

:

Careers that Change Lives

Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing and Operations. Supports the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met. 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. Responsible for coordination with other Geographies for International Regulatory Submissions, License Renewals and annual registrations

A Day in the Life

Supporting Design and Development Control activities with regulatory requirements, direction, tactics and strategies and working in a team environment with all organizational departments. Preparation of document packages for international regulatory submissions from all areas of company, internal audits and inspections.

Must Have

Job Responsibilities

\xc2\xb7 Prepare, review, file, and support premarket documents for global registrations for assigned projects.

\xc2\xb7 Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.

\xc2\xb7 Preparation of document packages for international regulatory submissions from all areas of company, internal audits and inspections.

\xc2\xb7 Compiles all materials required in submissions, license renewal and annual registrations

\xc2\xb7 Recommends changes for labelling, manufacturing, marketing and clinical protocol for regulatory compliance

\xc2\xb7 Monitors and improves tracking/control systems

\xc2\xb7 Keeps abreast of regulatory procedures and changes.

\xc2\xb7 May direct interaction with regulatory agencies on defined matters.

\xc2\xb7 Recommends strategies for earliest possible approvals of clinical trials applications.

\xc2\xb7 Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization.

\xc2\xb7 Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects.

\xc2\xb7 Develop Regulatory Strategies for new or modified products for assigned projects.

\xc2\xb7 Monitor and provide information pertaining to impact of changes in the regulatory environment.

\xc2\xb7 Communicate with regulatory agencies and/or notify bodies on administrative and routine matters.

\xc2\xb7 Document, consolidate, and maintain oral and written communication with health authorities

\xc2\xb7 Prepare internal documents for modifications to devices, when appropriate.

\xc2\xb7 Participate in health agency inspections & notified body audits as necessary.

\xc2\xb7 Author and/or review regulatory procedures and update as necessary.

\xc2\xb7 Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments.

\xc2\xb7 Assist in development/maintenance of regulatory files, records, and reporting systems of systematic retrieval of information.

Minimum Qualifications

\xc2\xb7 Bachelor\xe2\x80\x99s degree in Medical, Mechanical, Electric Life Science or other healthcare related majors

\xc2\xb7 7+ years experiences for RA role in medical device and or pharmaceutical industry

\xc2\xb7 Works independently with general supervision on larger, moderately complex projects / assignments.

\xc2\xb7 Contributes to the completion of project milestones.

\xc2\xb7 Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

\xc2\xb7 Communicates primarily and frequently with internal contacts. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making

Nice to Haves

\xc2\xb7 Excellent communication and interpersonal skills

\xc2\xb7 Excellent written, organizational, and communication skills is required, and have a flexible and team oriented attitude.

\xc2\xb7 Self motivated and positive

\xc2\xb7 Ability to quickly establish credibility with all levels of customer base

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.

Let\xe2\x80\x99s work together to address universal healthcare needs and improve patients\xe2\x80\x99 lives.Help us shape the future.

Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.

Medtronic